Please click on the titles below to go to the corresponding sample Case Evaluation Reports.
Hip Replacement Re-Operation Without Preventative Antibiotics Becomes Infected.
Let me first discuss the anatomy of the hip joint. The pelvis recess (acetabulum) is a hemispherical depression into which the ball shaped femoral head is seated. With a total hip replacement operation the acetabulum is scraped (reamed) to remove it's cartilage coating and a hollow cup of plastic and/or metal is inserted. The upper femur (thigh bone) is cut off just below its ball and angled piece of bone attached to that ball of bone. The femur shaft, hollow narrow cavity is reamed to accept the metal shaft of the prosthesis, which at the upper end has the metal ball part of the joint. The shaft is glued in place (or in some cases, has a rough treated surface to adhere to by scar tissue and bone growth).
This patient, eleven years earlier, she had a total hip replacement operation. As is too common, the components became loose, causing disabling pain. Surgery was indicated.
The standard of care requires prophylactic (preventative) antibiotics to be given by intravenous or intramuscular injection shortly prior to the onset of this or any operation in which foreign material (prosthesis and cement) is inserted into the body to decrease the risk of infection. Giving it after the operation does not prevent the risk, but only serves to slow down and mask the onset of any infection, which occurs. It is the Surgeon's responsibility to order this pre-operative antibiotic.
Dr. Jose obtained her consent and performed the total hip replacement re-operation on 3/8 on this 73-year-old lady. The operation began at 12:30pm and ended at 2:50pm. It was performed in the standard manner and was more difficult because of excessive scar tissue and the acetablulum bone was missing in its central location (which can result from any prior total hip replacement in bones, which are weak [osteopenic], which x-rays revealed by their reports). He added bone chips to "build up" this acetabulum defect, inserted the cup and implanted the cemented femoral prosthesis. All this was standard care.
However, the preventative antibiotic (Cefadil 1 gram I.V.) ordered "H.S." (hour of sleep) was not given and the dose "on call to O.R. (Operating Room)" was given at 7:30 am. The time she entered the operating room was 12:15pm with surgery at 12:30, thus there was a 5-hour delay, and the peak antibiotic blood level had long passed. Therefore she did not have the protection required for pre-operative prophylactic antibiotics. Why was there such a delay? Where was she from 7:30am until 12:15pm? Who was responsible for that delay? They were negligent. I cannot find any written order for this antibiotic. Who wrote it and would assume it was done? Was it a "standing order" (automatic routine) for this surgeon or hospital? The hospital is liable unless the surgeon knew of this problem with this patient or previous patients.
Unfortunately, the hip dislocated again. That usually is not negligent and 40 minutes after the conclusion of the first operation, she was taken back to the operating room at 3:30pm for a re-operation. This increased the risk of infection, was 8 hours after that antibiotic injection and without its protection. Dr. Jose was negligent for not ordering prophylactic pre-operative antibiotics again, for this operation. He reduced the dislocation and used wire to help hold the position of fractures of the femur shaft bone. Fractures with a re-operation is not negligent.
Unfortunately she dislocated again on 3/13 and that is not negligent. Dr. Jose re-operated to reduce it again and secured the separated bone. No obvious infection was seen, (only five days later), and it could have been suppressed by antibiotics, although Kefadyl would not kill the Staph germ. She did receive that antibiotic this day (apparently by chance) at 6am and surgery began at 8am.
I have not seen copies of any of these before and after hip x-rays and they should be obtained for Expert review.
She was placed on post-operative antibiotics and was discharged on 3/16 without any fever or signs of infection.
In the office on 4/9 she had an obvious wound (skin) separation and draining infection. A culture (for germ identification) and sensitivity study (to choose the correct killing antibiotics) was done. Those results should be available in two days. She was given the antibiotic Cipro. However, the germ was Staph Aureus and resistant to that antibiotic. She was not seen until four days later on 4/13. Two days too late, but was hospitalized that day for an Infectious Disease Consultation and care with three intravenous antibiotics (two of which were documented by the bacteriology test be effective).
A scan for bone infection (Technetium) and general infection (gallium) was negative. Although they wanted to keep her in the hospital with intravenous antibiotics, she refused to stay and was discharged home on 4/23. But they should have arranged for home intravenous antibiotic therapy. Oral antibiotics do not raise the bone blood level enough. However, the Defense would contend with no fever, normal bone scans and no deep signs of infection, it was a judgement call in a difficult patient.
The next records are those of Dr. Gregg on 10/27 noting that she could not walk for six months. Who was caring for her and did not recognize that that her pain and disability was very consistent with an infected hip? The x-rays revealed a loose prosthesis and missing bone on the femur shaft. He assumed it was infected and confirmed this by a germ analysis.
On 11/15 he operated to remove the entire prosthesis and cement, and inserted antibiotic containing spacer. She was transferred to a rehabilitation hospital to be maintained on intravenous antibiotics, but because of negligence, they were not given. Therefore she was re-hospitalized from 12/7 - 1/13 to restart them. She also had anticoagulation because of a non-negligent blood clot in her femoral vein. That was successful.
Then on 2/8 Dr. Gregg removed the implanted antibiotic hip spacer and inserted a new total joint prosthesis.
The failure to properly use pre-operative prophylactic antibiotics for her two operations on 3/8 was negligent and increased the risk for infection.
Did the Surgeon carry the Staph Aureus germ in his nose? Was the Surgeon and the Operating Room Staff tested? Did their Infectious Disease Control Committee follow up and follow through in their work to try to find the source of her infection? Was there a min-epidemic of increased Staph Aureus infections in February and March (which would require no elective operations until the source(s) were sterilized)? Therefore, there may be some liability by the Hospital.
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The Defense would contend that with her difficult operation on 3/8, there was an increased risk of infection. And when she was discharged there were no signs of infection, and with her re-admission the bone scans and temperature would support only a localized wound infection.
What happened next? If she had no persistent drainage, that would be suggestive of no hip infection, but with her increased pain, that is also suggestive for infection and repeat x-rays would have shown a loose prosthesis (sooner). But other than the pain and delay, the care of Dr. Gregg would have been the same.
As you can see, there are reasons to pursue this case. Please supply all the documents (good copies of x-rays and information), and then authorize the Medical Review Foundation, Inc. to have these records reviewed by Board Certified Medical Experts in: Infectious Disease and Orthopedic Surgery.
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Large Toe Fusion Surgery Becomes Infected and Because of Inadequate Care, Needs Amputation.
This 35-year-old incarcerated male previously had an attempt at a fusion at the large toe joint of his foot (first metatarsal – phalyngeal joint) which failed at union (solid bone), and its motion caused pain. A reoperative attempt at fusion by removing the previous hardware and freshening up both ends to healthier (bleeding) bone and the insertion of a compression plate, screws and graft material was indicated and properly performed on 3/29.
He received prophylactic antibiotics, which reduces the risk of infection, but obviously does not always prevent its occurrence. He was informed of the risks, and the need for proper postoperative care. A postoperative wound infection most commonly occurs in 7 to 9 days.
Once the skin is sutured closed, germs do not enter from the outside. However, with bloody drainage that sterile barrier is somewhat breached. I say somewhat, because the drainage flow will keep germs out.
He received clean bandages at his Correctional Facility. Sutures were removed on 4/14 as indicated. He was given more bandages. He had his “walking shoe.”
On 4/17, he was to receive a pillow to elevate his foot. This was not “permitted” until May 2 nd. Swelling (edema) decreases blood flow and swelling drainage, which to some small to moderate degree interferes with wound healing and by decreasing effective oxygenated blood flow (including germ fighting while blood cells). This can increase the risk of infection not resolving, and progressing.
On 4/18, he wanted his foot cleansed with peroxide, but the note said “without signs or symptoms (s/s) of infection.” If the wound was healing properly, he would not need cleansing with peroxide. Nurse Sally gave him “care.”
The medical records later claim that there was redness and drainage from after his last Orthopedic Surgeon visit on 4/7. He had “s/s” of infection and they were negligent for him not seeing a medical doctor at that time, and taken to his Orthopedic Surgeon.
On 4/24, although it was reported as a “lesion of foot healing fairly well,” he was prescribed a very low dose of broad spectrum antibiotic (Keflex 250 mg q.i.d.: four times a day), What “lesion” was there 26 days after surgery with a graft and plate inserted? Obviously it was infected.
The earlier the infection should have been properly treated: Removal of the graft, plate and screws, plus intensive and correct laboratory tests (based on laboratory tests: instant [gram] stain and culture and sensitivity) to try to contain the infection before it sets into the bone (acute osteomyelitis). After this is fully established, it results in his eventual outcome: preventable toe amputation on 5/22. Unfortunately, because of their negligence he did not get into a hospital for graft and hardware removal and debridement (removal of dead and infected flesh) until 5/17. The hospital care was good, but too late.
Nurse Sally cleansed the wound with peroxide and claimed “wound without s/s infection” on 4/18.
He needed more bandages on 4/24. But some healthcare provider with an illegible signature claimed: “healing fairly well,” and gave him the inadequate dose of antibiotics as I noted above. Intravenous antibiotics at the correct dose significantly get a higher level of antibiotics into bone, and that is the standard of care.
On 5/2, another healthcare provider (illegible name) said, “wound healing well, return in one week.” It could not be as stated. He needed to see his Orthopedic Surgeon.
On 5/8, another healthcare provider said: “Wound healing. Requests to see M.D. regarding antibiotic/tissue necrosis.” Necrosis (gangrene) is not “healing” and ominous. It opens up the wound to further outside germ contamination.
On 5/9, it says “foot healing well.” The Keflex antibiotic was renewed and he was to be seen on 5/10. This note was by another so-called healthcare provider.
On 5/10, under time it says Dr. Bob. It was now draining with a “hole” and “necrotic area” per their diagram. The necrotic areas were debrided (cut out). The dose and days of the antibiotic were doubled. All this was inadequate and further negligent.
Finally on 5/15, their record noted “Graft totally rejected” and he was sent to a hospital.
Who were each of these “healthcare providers?” What were their credentials (training and licensing at that time)?
The Defense would contend that the infection is a known risk, and with the foreign bodies (plate, screws and graft) the risk of progressive infection into bone comes on early and may not respond to the surgery he had on 5/17, and intravenous therapy no matter when begun. That is misleading. The earlier correct therapy is begun, the better the final result.
Once the infection had resolved, six months later he could have had another attempt at fusion with slightly higher risk of failure because with each operation, healing is lessened, and there is greater risk for infection because some dormant germs could be trapped in the scar tissue. But now he has no toe, and walking barefoot is impaired.
Obtain all the credentials of those so-called “healthcare providers,” and witness statements of his fellow prisoners at that time.
I would suggest that you authorize us to have all these records reviewed by Experts in Infectious Disease as well as Orthopedic Surgery.
You may want to also consider a class action lawsuit for all those who reside and resided at that and possibly other prisons. This is the tip of an incredible iceberg!
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Hip replacement operation for aseptic necrosis (gangrene of the hip joint) which became infected requiring more surgery.
This patient was incapacitated from her worsening hip pain. The x-ray studies revealed "aseptic necrosis," which is gangrene of the ball joint of the femur (thigh bone). It can be caused by steroid medications, alcohol and other medical conditions. I have not seen any indication of her previous medical care other than a few months of steroid injections of unknown dosage because of her hip pains.
She was fully informed as to the risks, and the operation was performed in the standard manner per the detailed operative report on 12/26 by Dr. #1. What is missing is whether or not she received prophylactic (preventative) antibiotics to reduce the risk of infection. The failure to give antibiotics immediately prior to and after the operation is negligence.
To give you that answer, I would need to see the missing pre- and postoperative Doctor's orders, the anesthesia records, Operating Room and Recovery Room Nurses' notes and the medication administration record.
She had a low grade fever postoperatively for a few days; that is not uncommon. Otherwise, she seemed to do well.
On 1/21, Dr. #1 noted signs of infection and obtained a sample of the joint fluid for infection. Germs were present (coagulase-negative Staphylococcus). Antibiotics did not cure this infection, so on 2/20, he removed the infected prothesis from the pelvic side of the hip area, washed out (irrigated) the hip joint and inserted antibiotics with cement, the standard of care.
Then on 5/15, he reoperated to reinsert the pelvic side of the prosthesis. All of this is standard, good care.
Her thrombophlebitis (clotting in leg veins) was properly treated with the anticoagulant (blood thinner) Coumadin. Again, good care.
She had a probable allergic (hypersensitivity reaction) to one of her antibiotics, and it was discontinued on 3/25. She received proper care for that unfortunate drug reaction.
The infection caused the loosening, a common complication. There was no over medication.
My only concern was whether or not she received prophylactic (preventative) antibiotics at the time of her 12/26 operation by Dr. #1. If she did not receive them, there would be negligence by Dr. #1. I need to see just those missing records I noted above.
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Re-operation to replace a loose cemented hip prosthesis causes sciatic nerve stretch injury.
This 78-year-old female patient had hip surgery for a hip fracture in four years earlier with the insertion of a bipolar artificial hip prosthesis. The pelvic side of the hip joint, the socket which is called the acetabulum, degenerated. That is an unfortunate "wear and tear" phenomenon. Therefore she underwent a total hip arthroplasty procedure in which there is both a total replacement of the femoral head (thigh bone ball part of the joint) as was done before, but also the insertion of a metal cup into the acetabulum by reaming it out for a perfect fit. These components are then glued in place with a special medical cement.
Unfortunately, this cement can lose its holding power as it is "attacked" by the body, and the prosthesis can loosen. Either part or both can become loose, and this usually causes significant pain, and therefore disability. That occurred in her case and was documented by x-rays of her hip on 7/10.
Therefore, a third operation was justified and performed by Dr. #1 on 10/29 at the Hospital #1, after answering all of her questions. In an operative report dictated that same day he said: "She was found to have a loose femoral component which was removed along with some proximal femoral cement without much difficulty. The acetabular component was also cemented and was loose. This was removed and all the cement was removed as well." Then he inserted both the femoral ball part of the joint as well as the new acetubular cup. The shaft of the metal part in the femur was cemented in place, and the acetabular cup "was press fit into place with no need for adjunctive fixation. The liner was snapped in with the 20 degree lip in the posterior superior position". This was properly done.
The Pathologist confirmed that he removed the "Three components of total hip prosthesis…"
Unfortunately, she sustained significant injury to her sciatic nerve. This nerve runs just behind the hip joint. She had two previous hip operations and Dr. #1 correctly elected to operate through a lateral (side) incision instead of a posterior incision which could endanger the sciatic nerve which would be entrapped in scar tissue from the previous two operations. However, in performing the operation through either incision, the hip joint has to be dislocated to get to each half. This can cause a stretch injury to the sciatic nerve, and did in her case. That is not from negligence. The risk of a stretch injury was somewhat higher because of those two operations. Using the lateral incision, the nerve is not identified as it would be with the posterior approach, but with the previous posterior incisions, operating again through a posterior approach significantly increased the risk of having the nerve cut, because it would be trapped in scar tissue.
In her case, the sciatic nerve injury was copiously well documented as occurring from the operation and she received all the proper physical therapy to aid her recovery.
The EMG (Electro-myogram) muscle test and the NCV (Nerve Conduction Velocity) study of 11/21 documented "… evidence consistent with a left sciatic mononeuropathy, axon loss in type, and severe in degree electrically".
On 12/18 Dr. #1 noted: "Her sciatic nerve palsy (weakness) is much improved. She has active eversion (outward twisting). Active ankle dorsiflexion (lifting up the foot). Sensation is improved as well. X-rays were satisfactory (for position of the entire prosthesis and the adjacent bone)".
And the repeat EMG and NCV of 5/21: "… there is evidence of significant reinnervation …" Both divisions of the sciatic nerve, the peroneal and tibial, were recovering from the stretch type injury. If the nerve was cut, burned, or torn apart, it would not recover.
Therefore, I can not find negligence in her care.
In younger patients, a porous prosthesis is more commonly used in which the healing bone grows into the prosthesis. But in more elderly patients, the results for rehabilitation are better with the cemented prosthesis, although there is a risk of loosening over years. I have not seen the records from the previous two operations.
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Diabetic foot ulcer, localized infection and then limited amputation.
This 54-year-old man was a long-standing insulin dependent diabetic. These patients will have small blood vessel disease resulting in loss of flesh in their feet, and increased risk of infection from their depressed immune system, which does not always respond to antibiotics, especially since they cannot reach where the blood circulation will not go.
On 1/26, he developed an infection of this fourth toe on his left foot, saw his doctor on 1/29 who cut out the obvious dead flesh, took a wound culture for germs and started him on a broad spectrum antibiotic (Ciprofloxin). All this is good standard care.
Unfortunately, this progressed to bone infection (osteomyelitis) based on the foot x-ray, bone scan and clinical examinations, and he was hospitalized from 2/15 through 3/2. He received intravenous (by vein) antibiotics and had an amputation of the fourth toe of his left foot, and further debridement (cutting out dead and infected flesh). All standard proper care
He was sent home with intravenous antibiotics and follow-up home nursing care (for which he had some conflicts).
Finally, because the infection did not resolve, he was hospitalized and had a partial amputation of his left foot on 5/6.
On 9/27 an x-ray and examination revealed an infection involving the base of the right large toe. They noted that: "The patient states over the weekend he noticed an open wound and some bleeding when he picked at one of the sores." This is poor patient compliance! That ulcer grew rapidly in size and he was hospitalized on 9/29 as an emergency. On 10/1 he had an emergency drainage of that right foot abscess. On 10/4 he had further debridement (removal of diseased flesh). All good and needed care.
The patient refused an amputation and received conservative therapy with antibiotics, wound care and whirlpool treatments.
Finally, he had to be hospitalized for an amputation of his right second toe. The plastic surgeon had just previously attempted a skin graft to close that wound, but it failed because of his disease.
They anticipated probable future amputation.
Unfortunately he had the common result of long-standing diabetes, worsened by a not totally compliant patient. I find no departures from the standards of care as a cause of, or contributing factor to his infections and amputations.
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Wrist fracture at age 73, with missed mid-forearm radius fracture.
At age 73, this man was involved in a high speed head-on automobile accident, and was saved by the air bag. However, he shattered his right knee cap (patella) and left wrist. The radius (main bone at the wrist) was crushed into itself, and this was immediately recognized, x-rayed and reduced under general anesthesia on 12/9, the same day as the accident. It was placed in a plaster sugar-tong splint.
Follow-up x-rays revealed "satisfactory position and alignment of the impacted comminuted (broken into pieces) fracture of the distal radius." He also had surgery on his patella. This part of his care was good.
However, on 1/30 the physical therapist said he "has a hard knot along mid forearm."
His Orthopedic Surgeon, Dr. #1 (who operated on 12/9) saw him on 3/11 and said: "We have x-rayed this area and found a displaced middle 1/3 fracture of the radius which is essentially healed with overriding of approximately ? inch and dorsal (backward) angulation." He is left-handed and: "Definitive treatment would require an osteotomy (operation to "re-break" it) to correct the shortening and malalignment." No guarantee of success could be given. I agree.
The standard of care requires a thorough examination for injuries by all the treating physicians and indicated x-rays. He had temporary loss of consciousness at the scene (amnesia) but was fully awake when he arrived at the hospital. All their care was good except for their negligent failure to fully assess his condition, especially his injured arm, since it is well known that at age 73, with that compression-type comminuted wrist fracture, the more proximal bone (toward the elbow direction) could also be broken (fractured). If there was any question on their examination, a forearm arm x-ray should have been ordered. On physical examination, he would have had pain at that site.
Once the cast was applied, depending on how high it extended, it could cover the mid-radius fracture site. How high did the cast extend? Was the cast changed? Was there mid-forearm pain and did he complain? Even by two weeks, it would be possible to reduce it without surgery. After that window of opportunity, surgery (osteotomy) would be needed. Obtain copies of all the "wrist" x-rays only. Possibly they may show the mid-radius fracture, and the failure to note it in the x-ray report would be negligence by the Radiologists. If it were present on any of those early x-rays, the Orthopedic Surgeon, Dr. #1 would be further negligent.
Did he complain of any mid-forearm pain to any of the nurses or the physical therapists? I have not seen their notes. Or did he complain of mid-forearm pain during any of his 12/12 - 12/18 stay in the Physical Therapy section of the hospital? Obtain those therapists' and nurses' notes.
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The defense would contend that they were focusing their attention on ruling out any life- threatening conditions, that the wrist pain overwhelmed any forearm pain, and that once he was put under anesthesia, had his splint / cast applied and was awakened, he had pain medication, which also suppressed any forearm pain. Also, the ulna, the other forearm bone at that site, is large and would serve as an internal "splint."
Supply a drawing of his whole forearm showing where each splint / cast reached and the date they were changed (if that occurred).
Also, at age 73 he would have a functional left arm with no forearm pain, and the major disability, if any, would be from his wrist fracture site.
There would be potential liability by the Emergency Room doctors (and their corporations) at both hospitals, Dr. #2, and Dr. #3.
Based on the number of potential defendants there may be a good potential for settlement with all parties contributing.
How much disability does he have? If it is significant, a videotape should be made to demonstrate that to all the defense attorneys.
Also interview witnesses who can validate this before and after impairment limited to his forearm.
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Wrist fracture casted but position lost; also develops Reflex Sympathetic Dystrophy (RSD) chronic pain.
Short Narrative of Facts:
At the time of the accident the patient was a 49 year old woman who fell down a flight of stairs at home and received a severely comminuted left distal radius and ulna wrist fracture labeled as a Colles fracture. Apparently discussion with Dr. #1, the attending surgeon, whether she should have a closed reduction and cast application or some kind of surgery is mentioned and finally it seems that the first option was chosen and Dr. #1 decided to do a closed reduction and long arm cast application of her fracture. We do not have any post operative x-rays and after an uncomplicated recovery and hospital stay she was sent home and had to come back a few days later because the cast was too tight. It was split on the side and she recovered full movement of her fingers and then she kept her appointment with Dr. #1 about l0 days later.
When she was first seen by Dr. #1, l0 days after her surgery, it was noted that neurovascular status was intact. She was still quite painful and repeat x-rays show maintenance of alignment and position although he reported there was severe comminution at the fracture site with the radial styloid.
It was also mentioned that due to financial reasons, the main reason being that she did not have any insurance coverage, that she would have to accept this and that she may require in the future an arthrodesis as a salvage procedure. He followed up again three or four weeks later with an out of cast x-ray. She would be put in a short arm cast the next visit.
When she came three weeks later, it seems that there was a lot of swelling in her hand and that she was unable to fully extend the middle and ring fingers. X-rays showed a loss of reduction, radial collapse and dorsal collapse of the fracture with severe comminution.
Dr. #1 mentioned that he reemphasized the importance of trying to correct this but it was reported that the patient refused to have any surgery.
Application of cast was for about nine weeks and during this time she received physical therapy to her fingers. She reports that there was pain during the time that the arm was casted.
After that she received further rehabilitation and physical therapy and she developed a RSD or reflex sympathetic dystrophy syndrome, an abnormal nerve pain condition. This was consisting of the region involving her fingers and her forearm to just distal to the left elbow. She was reporting burning and tingling sensations and involving primarily the dorsal aspect of her hand and wrist.
She was referred to Dr. #2 at the Pain Management Center for having a series of stellate ganglion blocks which is the recommended treatment for that condition, but she always kept some residual from the RSD and she still had the deformity of her left wrist. Apparently she had a total of seven ganglion blocks to try to reverse or improve her RSD. But she was still complaining seven months after the injury of a stiff hand, atrophied finger, and of being unable to make a tight fist, as well as she was unable to fully extend her fingers. This lady was working as a hotel maid and housekeeper and she was no longer able to do that function because of the condition of her left upper extremity.
She went to see Dr. #3 for a second opinion. He noticed that she had a malunion and nonunion of the distal radius of her left wrist and that she had significantly limited range of motion at the wrist. X-rays from March until May, which are not in our possession, showed that the fracture was not reduced and remained comminuted with dorsal displacement. His recommendation was to do a fusion of her wrist with plate fixation then excision of the distal ulna, or could take another alternative and to do a corrective osteotomy to put the wrist in a better position and to have more function out of it.
So basically after reading the statements of facts, it seems that the issues were that the fracture was not initially repositioned or maintained in that position and the fact that she also developed a RSD or reflex sympathetic dystrophy.
Standards of Care:
After reviewing the initial x-ray taken at the time of injury, we have a very comminuted and distal intra-articular (into the joint surface) fracture of distal radius associated with a fracture of the distal ulna. This is labeled a Colles fracture, and it is quite comminuted and quite unstable.
Standard of care for treatment of this fracture is usually to propose a closed versus open reduction and to try to restore as anatomic as possible alignment and to maintain it with any means possible. Classically those fractures were treated with a closed reduction and a cast with much palmer flexion and ulnar deviation. But the flaws or difficulties with that kind of treatment is that once the swelling is gone, the cast is not able to hold the fragments together and then they re-collapse in their original position, and this loss of position has led to multiple re-interventions. Actually the tendency now is to be more aggressive to do either a closed or open reduction, to use percutaneous K-wires or pins to try to hold the fragments together in the reduction.
Many surgeons are favoring a combination of an external fixator as well as percutaneous pinning if needed; it is a judgment call at the time of the surgery. Also, it was implied by the surgeon and the patient that she was given the option. She also showed some reluctance to having the surgery and she ended up having a closed reduction and a cast application. I think this falls within the accepted standard of care since the closed reduction and long arm cast is well accepted treatment for this kind of fracture.
When it is noticed that there is loss of reduction some further surgery or another reduction should be proposed and it seems that this is the case since I can document that, through Dr. #1's follow up notes. But the patient refused to have any surgery done and they decided to accept the malposition and to eventually do a salvage procedure consisting of wrist fusion. I do not have any x-rays during the follow up period to document how much loss of position or how the reduction was lost and since I can not speculate, I would say that so far everything is falling within the accepted standard of care.
Regarding the reflex sympathetic dystrophy, it is a well-known and very difficult syndrome to treat and sometimes there is much disproportion between the importance of the initial trauma and the severity of that syndrome. The reflex sympathetic dystrophy syndrome is something that is in relation to the initial injury and is a consequence of the left wrist fracture and has nothing to do with the treatment that was rendered. So it seems that this lady would have had a reflex sympathetic dystrophy syndrome regardless of the severity of her trauma and regardless of the kind of treatment that she was offered. It is just unfortunate, but there is nothing that she can do about it. It is just one of the malicious ways nature sometimes handles the complications lottery.
Impression:
Not any evidence of deviation from the standard of care based on the documentation and the x-rays that were provided to me. If there is documentation or proof that this lady was not offered the full course of treatment and that financial incentives were taken into consideration when treatment was rendered then that would change the picture. Actually that would be against the recommendations from the EMTALA regarding treatment to people without insurance. It specifically says that the kind of treatment rendered should not be according to the financial rewards that could be obtained from that treatment and people should be offered the optimum treatment regardless of their income or situation. Otherwise, since we are missing all the x-rays, I cannot speculate on the loss of reduction. It has been documented in the progress note that the reduction was lost and that the patient refused to have further surgery. This was her choice and we have to respect her choice and she has to l ive with the consequences.
Based on what I have seen on this case, I do not see much evidence of any deviation from the standards of care. I think it would be very difficult to find something wrong about the way the treatment was rendered or to find any evidence of negligence. It would be very difficult to find an Expert that would testify that there is definite proof of negligence in this case and at least based on the information that is provided and on the x-rays as provided.
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Shoulder injury with partial repair, reoperation failed, and then a third operation.
This patient was a 50 year old white Caucasian male, right handed, who was referred to Dr. #1after sustaining a right shoulder injury which was work related on February l4. He was attempting to get into a grader and slipped and fell and he was holding onto the grader when his right arm popped and he noted immediate onset of pain in the right shoulder and lateral epicondylar region of his right arm. He was referred to Dr. #1 who performed an investigation and clinical examination and believed that he may have had an impingement syndrome and a small rotator cuff tear. Finally Dr. #1 performed a subacromial decompression and rotator cuff repair on May l4.
Review of the preoperative evaluation work up was within standards of care. His symptoms failed conservative therapy and arrangements were made for surgical intervention which is the normal procedure. Apparently he had a torn rotator cuff of the right shoulder and this is basically a small tear on the hood of the shoulder where two tendons meet and are joined over the tuberosity of the humerus and sometimes, as the result of a fall, it impinges or it gets struck over the boney roof, which is the acromion, and this results in a small tear.
This was confirmed at arthroscopy and he did a small opening of the shoulder to repair the rotator cuff within the accepted standards and also did an arthroscopic subacromial decompression. Basically he made room to prevent his repair from impinging on the acromion after the surgery.
This is also standard procedure. Findings during this procedure was that he had a SLAP lesion or superior labrum tear which is basically a small detachment or tear of a gasket structure around the shallow cavity of the shoulder that promotes stability and increases the range of motion of the shoulder.
Finally there was a lesion at surgery but he felt it was not necessitating repair and anchorage and he just decided to debride that lesion and he says in his operative report that if not improved dramatically after the rotator cuff repair then he would address that particular issue with the possibility of additional repair of the SLAP lesion.
He improved after the surgery and was able to return to work. Apparently he had physically demanding work and activities and this led to an aggravation of his shoulder condition and the SLAP lesion was more symptomatic. So it was noticed by Dr. #1 that there was a progressive aggravation of his shoulder. In December, Dr. #1 performed a second surgery on the patient to repair the SLAP lesion and he put some anchors and repaired the SLAP lesion which is basically to repair that gasket or labral tear which was the cause of his instability and symptoms. Review of the details of the operative report from December l9 showed a standard arthroscopic technique to repair the SLAP lesion which was documented with pictures showing also that the rotator cuff repair done a year before was still patent and Dr. #1 debrided the glenoid and burred down two holes so that he was able to put two mini anchors which are metallic anchors with sutures attached to it and using a shuttle technique he passed the sutures and tied the labrum tear holding the base of the biceps against the bleeding neck of the glenoid.
So there was basically an indication for that arthroscopic repair since it was noted at the first surgery. The technique and the procedure employed is within the accepted standard of care. After his second surgery the patient went through approximately 8 months of physical therapy in which focus was on restoration of function of his shoulder but he was not progressing as expected and was not able to go back to work. He was complaining of persistence of some instability and some pain starting about the tip of the acromion and radiating down the anterior portion of his shoulder. He was in a drivers program and was taking college courses in office technology.
In December this patient became under the care of Dr. #2, who is another surgeon and it was noted that he was a heavy equipment operator and he was describing the two surgeries that he went to and the fact that the last repair and surgery was not completely relieving his symptoms. Dr. #2 mentioned that the SLAP injury was present at the first surgery and that the surgeon decided not to repair it, which is also within the accepted standards of care. It was the surgeon's decision and a judgement call. He also noticed that he had at the acromioclavicular joint, which is the small joint in between the tip of the shoulder and the clavicle, some sign of arthritis that was partially treated by the acromioplasty that was done initially.
He was mentioning that it was not completely addressed and that this could be improved by a more generous acromioplasty. He was remaining with scapular symptoms and at the end of his physical examination he was symptomatic of a multidirectional instability of his right shoulder which basically means that his shoulder was slack and going in every direction causing a pain at the anterior portion. MRI scan which was done prior to his evaluation was showing arthritis at the acromioclavicular joint, evidence of a previous SLAP and rotator cuff tear repair and metallic anchors which were present due to the metallic effect on the MRI scan.
Because of persistence of symptoms it was decided to do an arthroscopy with the possibility of acromioplasty and this was performed February 1. Apparently the findings were that he had reinjured his SLAP lesion. Basically he had detached the labrum or lip which is a gasket type of structure around his glenoid cavity and this was creating instability in every direction of his shoulder. It was somewhat of a surprise since Dr. #2 was not expecting that and he decided to do a full repair by inserting three anchors and sutures to repair that defect and reattach the labrum. Also he did a shrinkage of the capsule to stabilize the shoulder and make it tighter.
This is well detailed in his operative report where pictures were taken and also after reviewing the videotape with sound and comments from Dr. #2 explaining his findings and his procedure. It was quite interesting to review this video which is about 1 1/2 hours long. As asked specifically, I paid attention to notice that the anchors that were put by Dr. #2 were present and identified by Dr. #2 during his arthroscopic procedure.
He was not able to find the sutures but they could have been of the resorbing type and were not found. Also an explanation could be that Dr. #1 described that he reattached the labrum around the biceps portion and those were not clearly identified and there was no particular problem in that area as seen on the video. There was a labrum tear which was more superiorly and anteriorly and this was addressed by Dr. #2. There was a definite indication for the surgery. The surgery was done within all the accepted standards of care. As a comment, I could say that Dr. #2 is a very gifted surgeon and he is quite skilled in shoulder arthroscopic techniques.
He was normally followed by Dr. #2 after his surgery. He was seen on the l6th and 28th of the month of February and was showing evidence of increasing range of motion. The shoulder was feeling good. Range of motion was increased and he was continuing in the rehab program and strengthening exercises under the guidance of Dr. #2. No further evaluation was done. Apparently the problem was fixed and he seemed to be improving as expected after that surgery.
I carefully reviewed all the information that was provided to me as well the video and I have to admit that it is a very difficult problem to treat and although arthroscopic techniques are used they are limited and are more demanding technically. There was a definite indication for the first surgery and it was a judgement call not to repair the SLAP lesion that was noticed. It was not a deviation and there is nothing wrong in doing so.
The second surgery was attempting to repair the SLAP lesion which was actually a detachment of the labrum or gasket structure around the shallow cavity of the shoulder and this was done according to standard techniques within standards of care. Since the repair, when it is done under arthroscopy, is not as solid as when it is done in an open fashion, it is subject sometimes to failure or re-injury.
This was confirmed at the third surgery as performed by Dr. #2 that there was indeed a rotator cuff repair which was done and was still lasting and that the anchors that were inserted to try to repair the SLAP lesion by Dr. #1 the second time he performed surgery, were found. He seemed to have worked in a more anterior and under the biceps tendon and from reviewing the video there was no evidence that there was a re-injury in that area but the SLAP lesions seems to have progressed and was situated a little more superiorly and in a different area than initially seen by Dr. #1. Dr. #2 fixed the problem and it is not uncommon to see a re-injury, possibly due to the type of work the patient was exposed to or due to the fact that the lesion was possibly incomplete at the time it was taken care of by Dr. #1 and continued to progress.
In correlation to this is the fact that the MRI that was performed prior to Dr. #2's surgery was not able to find a definite SLAP lesion and it was somewhat of a surprise when Dr. #2 went in since he was going in for a different thing and thinking that he would not have to do a complete SLAP lesion repair.
In conclusion, this gentleman was adequately and appropriately treated. There was appropriate indication for the surgeries and all the surgeries were done within the standards of care. I do not find any evidence of any negligence on the part of Dr. #1 and if someone is trying to reproach him the fact that he did not repair the SLAP lesion the first time or that he did not repair it completely the second time would be completely erroneous and I do not see any negligence on his part.
It was a judgement call the first time and is commonly done and the second time there was no guarantee that the repair would last forever since it is technically demanding to do that under arthroscopy and the results are not as good and longstanding as when you do an open procedure. The intention to do arthroscopically is that the recovery is faster.
With this case, I would not recommend to pursue any further actions and since I do not find any evidence of negligence or deviation from the standards of care it would be very difficult to find an Expert to say the contrary or to sustain any such allegations.
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Possibly unnecessary lumbar fusion operation and superficial wound infection.
According to the Surgeon, Dr. #1, this patient was a failure of conservative therapy by her private physician, Dr. #2, whose records I have not seen nor do I have any details of that therapy. If that therapy was not "reasonable," the operation for pain should not have occurred, and therefore there would not be any superficial chronic wound infection.
Dr. #1 believed her back had disease based on the MRI, however that MRI, on 9/21 said: "Mild multilevel degenerative facet disease," but "No significant change in the degenerative disc disease at L5/S1 level," so why operate unless true conservative therapy was tried and was unsuccessful? The operation's justification by Dr. #1 was to prevent slipping of one bone over another (listhesis), but that "crystal ball" approach is too aggressive.
So was the operation justified? All the above concerns are relevant.
With a lumbar fusion, especially with the use of the "cage" to aid the fusion, preventive (prophylactic) antibiotics with an intravenous dose just prior to surgery, and for a few postoperative doses is the standard of care. She received the broad-spectrum antibiotic Ansef before and after surgery on 1/6 and 1/7.
While in the Hospital there was no wound evidence of infection. Afterward she had a superficial wound infection which was caused by the germ Staphylococcusaureus that got into the wound in the operating room, and was treated properly in the office with antibiotics and wound care. When that did not cause it to heal, she was hospitalized from 3/9 through 3/10. She had a wound cleansing (debridement) operation that found nothing unusual except this chronic infection. She received long-term intravenous antibiotics, and good follow-up wound care.
A wound infection of this nature is an unfortunate maloccurrence and not negligence, unless the operation was unnecessary as I noted above, or unless there were failures of infection prevention procedures in the hospital, or if Dr. #1 was a "carrier" of the Staphylococcus germ (in his nose and throat). To follow up on this issue requires obtaining the infectious disease protocols and rates of infection that were present in January in the Hospital #1. Was the infection rate too high at that time? How did they investigate this infection and what did they find as a possible cause? Were there breaches in sterilization practices?
The bone fusion site did not become infected. Therefore the damages are limited.
If you want to pursue this case, the preoperative therapy needs to be evaluated, as does the infectious disease procedures as I noted.
I suggest that the patient be evaluated by a local Clinical Psychologist with courtroom experience for any residual emotional (psychological) damages. Administration of standardized tests such as the M.M.P.I. (Minnesota Muliphasic Inventory) which have been given to millions of people would further support that opinion before a jury.
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Compound and comminuted knee fracture repaired with a metal "T" shaped plate that broke and the fracture site did not heal with solid bone.
This 46-year-old morbidly obese male fell 15 feet from a ladder and sustained a skull fracture and a compound/comminuted fracture of his lower right femur (thigh bone) at the knee. The broken piece of the femur protruded through the skin. The lateral and medial condyles (both halves of the knee joint of the femur) had been broken off, and the lateral (outer) condyle was also broken in half. That portends a poor result regarding a pain-free knee, because the fracture entered the knee joint.
After stabilization and transferring him to the Hospital on 12/11, and obtaining informed consent, and with proper antibiotic therapy he was taken to the operating room by Dr. #1, the specialist in Adult Reconstructive Orthopedics.
This difficult fracture was cleansed (debrided), reduced and a T-shaped distal femoral condylar plate was correctly selected to use to hold these pieces of bone together to try to allow healing. He said: "In view of the bone loss (which would further impair healing), the very large size of the patient and the open nature of the injury, this reduction was selected." Local bone was also used as a bone graft.
After surgery he did not get an infection at the fracture site (clinically and confirmed by negative germ analysis [gram stain and culture and sensitivity studies] at the next operation).
He was not to be weight bearing and then slow progressive exercise was allowed. A knee brace was used, and that would take some weight off the fracture site. Postoperative x-rays showed progressive healing and by x-ray report it was healed on 6/15. No x-ray report mentioned a broken plate.
However, he actually had a "non-union," where the scar tissue and not solid bone united the fragments. This is a known complication. Possibly the broken plate may have increased that risk. Did he always follow his post-operative instructions? Did he ever have another seizure? Did he do excessive work, putting too much force on this leg too soon?
On 9/2 Dr. #1 reoperated, removed the screws and the "broken buttress plate," cut out the scar tissue and inserted a 10 hole, 80 millimeter (3 inch) blade plate. He also performed an indicated (at this reoperation) major bone graft.
I have no follow-up information. Did it heal?
I doubt that we will be able to obtain a supportive Orthopedic Surgery Expert opinion. However, if you want to pursue that opinion, answers to the questions above are needed, plus good copies of all the knee (lower femur) x-rays from prior to the 12/11 operation through after the 9/2 operation. Then an Orthopedic Surgeon will be able to give you a definitive opinion.
The future potential for arthritic knee damage was directly related to the 12/11 injury with the fracture extending into the knee joint and its fragments, plus original bone loss, resulting in a less than perfect anatomical reduction. I do not believe that would be from any substandard care, but that Orthopedic Surgery Expert could also assess that issue best by seeing those x-rays (copies).
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Biceps muscle/tendon rupture with delayed surgical repair causing weakness.
On April 20, the patient fell and caught himself with his right arm, injuring the tendon and biceps muscle of his right arm. At that time he weighed 247 pounds.
In the Emergency Room the plain x-rays showed no fracture. That physician noted: "Suspect tear of the biceps muscle" and the patient was referred to an Orthopedist.
When the tendon ruptures, the muscle contracts like a rubber band, and over time, scar tissue forms from the torn flesh, and the muscle atrophies (degenerates). As the weeks and months pass, its length is lost. With delayed surgery after that time, it is not possible to sew the two ends of the tendon together. To fill in that gap, another piece of tendon, as a graft, has to be sewn in place. However, without gaining the original muscle length, strength is lost. The muscle "lump," a cosmetic deformity can be corrected by that delayed surgery, but the loss of strength damage from an excessive delay would not be corrected.
Based on the medical history, and physical examination findings, the torn (ruptured) biceps tendon should have been suspected much sooner. A MRI examination should have been done and that would have documented the details of his injury.
The Internist who was treating his hypertension saw him on what appears to be 4/22 and saw a "large ecchymosis" (black and blue discoloration from bleeding into his flesh) and said: "possible torn muscle". He was referred to an Orthopedic Surgeon, Dr. #1.
I have not seen the office records of Dr. #1, but your letter states that he concluded: "right arm hematoma, ruptured muscle, resolved". He was to return to his "regular duties".
Did the lump really resolve? If so, then it was a partial tendon rupture and tear in the muscle, or bleeding into this muscle.
Your letter noted that "On July 15, the Patient again presented to Dr. #1 complaining of a painful lump on his right arm and numbness in right hand fingers. Upon examination, the lump was a tender mass of 2 1/2 centimeters (one inch), hard, movable but severely attached to the muscle".
Did this suddenly develop in July? That would mean the tendon fully tore at that time, and the failure to diagnose a partial tear earlier, would be "excusable" under the circumstances, because the typical ball of muscle and impaired flexion would not have been present. Bleeding into the muscle from some torn fibers would be treated conservatively, since it would resolve and heal over time. A torn tendon is repaired surgically without delay.
He was referred to Dr. #2, an Orthopedic Surgery Professor. He saw the patient on 9/21, not July. Why was there a delay? Dr. #2 concluded that "there is a soft, freely mobile soft tissue mass present over the anterior surface of the right arm. This, in all likelihood, represents avulsion (ripping apart) of the biceps with contraction".
He had electrical nerve and muscle tests (NCV and EMG) which revealed compression of the median nerve at the muscle scar tissue area from this injury, and at the wrist (carpal tunnel syndrome), probably not related to his injury.
Both operations to free up the nerve on his upper arm and wrist took place on 12/22 by Dr. #2, and were properly performed. The findings were as anticipated. The patient recovered and did well, except that the biceps tendon problem, which was not repaired, still was bothering him as Dr. #2 noted on 5/10, a year after the injury. He recommended surgical reconstruction with the use of an Achilles tendon allograft (from a cadaver).
If the muscle lump was present from the initial injury, it would mean that the tendon did rupture at the time of the accident, and not from a partial tear that became a full tear from further use of his arm. The failure to diagnose and treat it on time would be negligent and resulted in the scarring and loss of length (contracture) as well as the scar tissue trapping the median nerve in the upper arm, resulting in the surgery to free up that nerve, and the need for future tendon graft surgery. However, his strength will never be 100% because of the delay and contracture.
It is critical to obtain a detailed statement (preferably affidavit) from the patient and all witnesses to his biceps muscle condition from the time of the injury through at least mid July. Also obtain all the office records of Dr. #1.
At that time, all the records should be evaluated by one of our Orthopedic Surgery Expert Witness Consultants, pursuant to our Fee Schedule.
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Severe ankle fracture with operative reduction, probably delay in antibiotic use, infection, and two attempts to fuse that ankle.
On January 17 this 40 year old man fell six feet and sustained a severe displaced fracture of his ankle joint (" plafond fracture of the left tibial bone with a posterior fragment displaced proximally, and has a transverse and an oblique fracture of the plafond, which are non-displaced"). Because of the significant displacement (fracture fragment shifting out of position), the operation to align (reduce) the fracture and secure it in position with screws was indicated.
Dr. #1 performed the correct operation on January 17, under spinal anesthesia. I have not seen the pre-operative orders, the pre-operative medication record and the anesthesia record to determine whether or not pre-operative and intra-operative prophylactic (preventive) antibiotics were ordered. Based on the nature of the operation, with the insertion of metal screws into the bone, in my opinion they should have been used, to achieve an adequate blood level at the start of the surgery, where it has been demonstrated to have an effect. If given more than an hour after the start of surgery, especially here where a tourniquet was used, it would not have a significant effect to prevent an infection.
According to the "medication administration record" the first post-operative dose of the antibiotic Kefzol was given at 2359 (11:59 p.m.) on January 17. It was ordered by intra-venous injection as 1 gram every 6 hours, for 48 hours. I do not know what time he went into the operating room. There may be negligent failure to properly give this patient the antibiotics to reduce the risk of infection. Also obtain the anesthesia and recovery room records.
Upon discharge, according to the "Discharge Summary" he was to take the oral antibiotic Cipro because of concern for infection. This is acceptable. He was discharged on January 20 and the home health service "medication profile" notes that on January 22 he was to take this antibiotic two times a day for 5 days. Considering that the ankle drainage persisted and his ankle was swollen and red, Dr. #1 should have sent a sample of that drainage fluid to the laboratory for germ analysis (gram stain plus culture and sensitivity) sooner than he did, to see if it was infected and be able to select the best antibiotic to use, by intra-venous injection to obtain a high blood level to kill germs in the bone, since it is not reasonably possible to do by oral (pill) intake. On February 4 a sample was obtained and the initial report showed germs after 1 day, and the final report was ready on February 6, Dr. #1 properly ordered the intra-venous use of the antibiotic Vancomycin.
At that point, most Surgeons would hospitalize the patient and remove the screws which serve as a "foreign body" and to some degree prevent the body and antibiotics from killing all the germs (sterilize the bone and adjacent flesh). Under those circumstances, I believe that to be a departure from the standards of care.
Dr. #1 decided to remove these two screws on March 10, for the reason I explained. After a day delay in getting a wheel chair "approved," the patient changed doctors.
Good copies of the ankle fracture and post-operative x-rays will be needed for an Orthopedic Surgeon Expert to review to determine if Dr. #1 properly (anatomically) reduced the fracture, and followed it up, to be sure no fragments again displaced. Also obtain those x-ray reports.
He came under the care of Dr. #2 on March 23, and when he took x-rays he noted: "There is a significantly larger posterior plafond fragment that has displaced with the talus (foot bone part of the ankle joint), and the ankle has lost its normal congruity with a plantar flexion deformity of the talus." Obtain a copy of those x-rays, too.
It was his belief that this patient now required "an ankle arthrodesis (fusion) for final resolution". I agree. He wanted the fracture to first heal, so that the next operation (to fuse the ankle) had a reasonable chance of solidifying. He correctly recommended an electromagnetic bone stimulator, at this stage of poor healing, to improve the chance of the fracture healing. He made a judgement call to leave the screws in place unless he detected "a frank abscess or drainage". By this time the infection had markedly reduced the chance for the fracture to heal, and there was no more drainage.
By June 17 there was no sign of bone infection (osteomyelitis) and the patient "has continued to complain bitterly of pain in the ankle and swelling of the ankle and foot related to this post traumatic arthritis". Dr. #2 performed the left ankle arthrodesis with the use of a new screw (he removed the two screws that Dr. #1 had inserted) and used a bone graft. On June 26 he said that the "Radiographs (x-rays) reveal the ankle joint in good position with excellent bone opposition". Healing of the fusion was noted on the x-rays of July 10.
However, Staph aureus was cultured and oral antibiotics prescribed, on July 10. I do not know how much drainage was noted, if any.
By September 21 healing was incomplete and he re-started the use of the bone stimulator. The patient did not return for monthly visits until March, six months later. There was non-union (scar tissue instead of solid bone at the operative fusion site), and his ankle was swollen and painful. Therefore, a repeat fusion attempt by Dr. #2 was justified, and performed correctly on June 9.
On June 17 the alignment was "excellent" by x-ray, and August 10 it was healing well. His pain was relieved and his ankle was "clinically stable". I have no further records.
The care by Dr. #2 was good.
I have discussed the few concerns of potential negligence of Dr. #1 which relate to whether or not be started prophylactic antibiotics before the tourniquet was pumped up during the first operation and how soon the next dose was given. Did he achieve anatomical alignment? That answer will be in the x-ray reports and copies of those ankle x-rays. If there were delays in outpatient (home) antibiotics, whose fault was that since the discharge summary dictated on January 20, three days after that first operation noted: "He was to take Cipro for antibiotic coverage". The bloody drainage noted by the nurses in the hospital can be seen after that operation and would not be from a wound infection after a few days. His delay in culturing the drainage for germs in late January, in my opinion was negligent. He did it on February 4.
Even with perfect care, his ankle may have developed severe arthritis from the damaged cartilege, bone, and ligaments. His best chance for a useful and pain-free ankle, for a number of years depended on excellent (anatomic) alignment at the first operation, and no infection occurring. An infection reduces the chance for the fracture to solidly heal with bone solidly bridging the fracture site, rather than scar tissue.
Please obtain the missing records I requested above, the x-ray reports, and copies of the x-rays. I suggest that you authorize us to have these records reviewed by Experts in Infectious Disease first, and then Orthopedic Surgery for their opinions.
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