PLEASE COMMENT ON THIS CASE ONLY IF YOU ROUTINELY PERFORM TOTAL ANKLE REPLACEMENTS.
A 53 year old woman, ex-college soccer player, had continued playing soccer and other sports (tennis, basketball, cross country running) into her early 40s. She had sustained a series of “ankle sprains” throughout her athletic career. Eventually, she developed chronic ankle pain interfering with daily activities and sleep.
She was diagnosed with primary localized osteoarthrosis of left ankle and foot, as well as varus deformity, and was recommended surgery.
March 8, 2021 – FIRST SURGERY
Operation: Left vantage total ankle replacement, achilles lengthening, open reduction and internal fixation of medial malleolus, brostrom lateral ankle ligament repair.
The operative report mentions: (…) Patient-specific instrumentation was placed and was later used to make the cut. However, it was necessary to revise the talar cut for good positioning which was achieved. (…) After the tibial component had been placed, the flat-top talar component was impacted into place, was in good position, and had good apposition on the lateral view. Finally, an 8 mm poly was placed. A 6 mm poly had been trialed, but showed instability and therefore the 8 mm poly was placed. However, the 6 mm poly was placed to allow for the repair of the lateral ankle ligaments which was done separately. (…) The 8 mm poly was then put in place.
It was noted that the medial malleolus was thin and was at risk of stress fracture. Therefore ORIF of the medial malleolus was done. Incision was made at the tip of the medial malleolus after a pin had been placed and an Exactech 4.0, 44 mm screw was placed.
The ankle was noted to be tight and therefore a tri-cut Achilles lengthening was done, so that 5-10 mm of dorsiflexion was achieved.
Final x-rays showed good apposition at the AP and lateral views.
The reason for the revision of the talar cut, deemed by the surgeon to be “necessary”, is not specified in this operative report. Nor is there an explanation of the reason that the medial malleolus was at “risk of stress fracture” thereby requiring an ORIF.
After this operation, the patient had been experiencing constant pain, worse with weight bearing. The pain was described as shooting, burning or throbbing, with some paraesthesia in the foot at times. Work up included CT and SPECT, and resulted in a diagnosis of left lateral impingement distal gutter ankle replacement, possible impingement medial gutter, stress reaction medial tibia.
Re-operation was recommended.
June 14, 2021 – SECOND SURGERY
Left ostectomy medial tibia, ostectomy medial talus, ostectomy lateral talus, ORIF medial malleolus, poly exchange ankle replacement vantage, ORIF Talus.
The Op Report mentions: (…) Obvious lateral impingement was seen in the distal gutter. The lateral gutter was identified and confirmed under fluoroscopy. An osteotome was used to fashion the cut. In excising the piece, probably due to soft bone, more talus was excised than planned. The portion that was not necessary to remove was placed back and fixed as in a talus fracture with three 2.4 screws with excellent alignment and good fixation. An incision was then made anteriorly over the ankle replacement. (...) The distal gutter was noted to have some growth of bone along the medial talus and tibia. These were removed with a rongeur and pituitary. No visible fracture of the medial malleolus was noted. However, the patient had considerable pain and tenderness over it despite fixation with one screw. Therefore, an ORIF of the medial malleolus was done. A second cannulated Vantage screw was placed along the medial tibia with good fixation.
To adequately debride the gutters, it was necessary to remove and inspect the 8-mm poly. At the end of the procedure, a new 8-mm poly was placed as well as the clip.
The patient had good motion. Final x-rays showed good alignment of the ankle and subtalar joint and good placement of the fixation. The gutters did appear to be clean with no impingement on direct inspection and under x-ray evaluation.
On August 30, 2021, Exactech, Inc. initiated a Class 2 Device Recall for the “Vantage Total Ankle System” as these devices are/were subject to an increased risk of polyethylene wear (erosion), which “can initiate a variety of clinical issues to include device loosening, device fracture, mechanical failure, pain, bone loss or recurrent swelling in the affected area”.
The hospital where the patient underwent the TAR related surgeries received the manufacturer’s recall letter on February 8, 2022.
Meanwhile, the patient was still having pain on the lateral aspect of the left ankle, worse with activities. She required a boot. CT scans and X-rays showed that the fixation screws implanted by the surgeon during the first and second surgeries were “proud to the bone”. She was advised to go back to the OR for removal of bone spur and ROH from left lower extremity.
March 10, 2022 – THIRD SURGERY
Left Ostectomy Fibula, Ostectomy Talus Separate from Removal of Hardware at Talar Process and Lateral Talus, Ostectomy Calcaneus Peroneal Tubercle, Repair Peroneus Brevis, Tenosynovectomy Longus, Removal of Deep Hardware Screws Talus.
Postoperative diagnosis reads: exostosis fibula, exostosis talus, exostosis calcaneus peroneus tubercle, tear peroneus brevis, degeneration peroneus longus, retained hardware talus.
The Op Report mentions: (…) Exostosis was identified as noted on the preoperative weight-bearing and non-weight bearing CT scans. It was resected with an osteotome, smoothed with a bur. The whole area was smoothed with a rasp. A good smooth surface was achieved and full resection done. Incision was then made over the sinus tarsi. The area of the previous fracture was identified and was noted to be healed well. A portion of anterior talar process was removed with an osteotome, as some impingement could be seen in the Operating Room with eversion of the subtalar joint. Once this was done incision was made further proximally and at a separate location, two screws were removed one of them being too long and potentially prominent in the medial gutter. X-rays of the medial gutter showed once the screws were removed, the prominence of the screw was gone and no impingement in the medial gutter could be identified.
Incision was then made further distally. The peroneal tendon was inspected. The peroneus brevis was noted to have a split; this was repaired with 2-0 Vicryl suture. The longus did not have a split but had an area of degeneration. A tenosynovectomy was performed and the most degenerated portion was trimmed. The tendon had good range of motion and no impingement was noted. The peroneal tubercle however was prominent; it was running against the tendon. Additional incision was made and lateral dissection along the calcaneus. The lateral calcaneus, the peroneal tendon was removed with an osteotome and the area was smooth with a rasp.
Two screws were removed during this operation as per the surgical pathology report. Were these screws placed incorrectly? The screws were described as being “too long and potentially prominent in the medial gutter”. Were incorrectly sized screws implanted? Were the screws responsible, in whole or in part, for the patient’s severe ankle pain after the surgeries?
In a letter to the patient, dated April 25, 2022, the hospital informed her of the recall regarding her ankle implant as well as the signs and symptoms of an implant device that is either defective or experiencing premature wear: unusual pain or aching, swelling, redness, stiffness, difficulty moving and/or instability.
Patients was seen post-operatively in the clinic and seemed to progress well during the first few months. However, by July 2022 she was experiencing cramping, and was requiring gabapentin. X-rays demonstrated good alignment of the implant.
During a visit in November 2022 the surgeon noted: Discussed the poly recall for her implant. Would investigate further if the symptoms change likely with a SPECT. She should get an X-ray every year and come in sooner if symptoms change. We would get an MRI to eval her peroneal tendons, but she had a burning pain with her prior MRI so we will first get an ultrasound. Will also eval sural nerve on ultrasound. Numbness could be related to that surgery if it is just in the distribution of the sural nerve or could be related to a block. She did have some numbness after the original surgery in her plantar toes and that numbness could be involved without surgery and/or anesthesia.
Questions:
Are the intraoperative iatrogenic fractures of the medial malleolus, the erroneously excessive resection of talus requiring multiple ORIFs, and ORIF screw implants not flush to the bone evidence of departures from proper orthopedic practice? If so, did these surgical misadventures cause or contribute to the severe postoperative neuropathic pain and consequent disabilities and gait disturbances experienced by this patient?
Files:
Q: Was the initial varus alignment addressed? Best evaluated by postoperative xray
A: —
Do you believe there might have been medical error?
The operative report unfortunately reads like a comedy of errors. Cuts are made erroneously and need to be revised. Medial malleolus insufficiency is encountered intraoperatively as if it were a surprise. Multiple surgical revisions where "obvious" issues are later identified that could/should have been identified in the index surgery. I would have to review all the radiographs to say for sure, but this does read like multiple medical errors and poor surgical technique. Possibly poor judgement as well.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
There is likely causation here. The poor technique may also have led to a nerve injury, a common and sometimes preventable complication of ankle arthroplasty. This would explain the patients severe naturopathic type pain.
What makes you a good expert for this case?
I am a board certified orthopedic surgeon and I have experience doing expert witness consulting for both the plaintiff and defense sides.
How often do you encounter cases similar to this one in your practice?
Neuropathic pain is a frequent consult in my practice. I also occasionally see iatrogenic injuries and post operative complications from arthroplasty.
Do you believe there might have been medical error?
Not uncommon to place a screw in the medial malleolus to prevent iatrogenic fracture. Gutter impingement post surgery can happen. The patients postoperative pain could have been the peroneal tendon tear.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The issues of this case are not due to lack of standard of care, rather, potential complications that can happen even in the best of hands.
What makes you a good expert for this case?
Board certified fellowship trained in Foot & Ankle surgery, have worked as expert prior and have been deposed as treating physician for plantiff and defendant cases.
How often do you encounter cases similar to this one in your practice?
I perform 1-2 total ankle replacements per month.
Do you believe there might have been medical error?
The iatrogenic fracture of the talus, which required intraoperative fixation, was a medical error. It was appropriate to fix this talar fragment rather than excising it. On many occasions, the medial malleolus can be a bit thin following tibial resection for total ankle replacement. Many surgeons prophylactically fixate the medial malleolus at the time of the initial total ankle replacement even without a fracture. It is not clear to me in this case that there was ever a true medial malleolus fracture but screws were used to prevent fracture. Medial and lateral ankle gutter impingement is fairly common after total ankle replacement and would not be considered a medical error. The screws being too long in the talus and requiring later removal is a technical error. It is possible that there was a sural nerve injury or neuritis following peroneal tendon repair. Sural nerve irritation following peroneal tendon repair is a known risk. Most cases of sural nerve irritation/neuritis resolve over time and do not require further surgery. The fact that the Vantage polyethylene was recalled is out of the control of the surgeon. I would consider exchanging the polyethylene if there was evidence of osteolysis on imaging. Please note: It is difficult to make definitive statements without seeing the x-rays, CT scan, SPECT scan, etc.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
It is not clear to me that an "injury" was caused by the above medical errors. The iatrogenic talar fracture was a medical error but was immediately addressed at the time of surgery. A thinned medial malleolus that is stabilized with a medial malleolar screw is considered standard of care with total ankle replacement. Gutter impingement requiring additional surgery is unfortunately not uncommon following total ankle replacement and sural neuritis after peroneal tendon surgery is not uncommon. Hardware removal for symptomatic hardware is commonly performed. Please note: It is difficult to make definitive statements without seeing the x-rays, CT scan, SPECT scan, etc.
What makes you a good expert for this case?
I have performed total ankle arthroplasties (replacements) for the last 9 years. I have experience with primary and revision procedures, including revision total ankle, polyethylene exchange, gutter debridement and explantation.
How often do you encounter cases similar to this one in your practice?
I encounter approximately 5 cases of gutter impingement per year. I encounter several painful total ankles per year, which require further treatment, including surgery.
Do you believe there might have been medical error?
Intraop medial mall fx is known potential complication thus prophylactic screw stabilization is appropriate. The term ORIF is a bit misleading….there was not a true fx. Excessive resection of the talus in second surgery requiring fixation is outside the norm as is long screw length in an area that could cause painful impingement. Did the patient have documented osteopenia that contributed to the excessive cut? The recall of the poly in this implant does not appear to apply. Nerve pain is more likely attributed to multiple surgeries within a year.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The excessive Talar resection and subsequent need for fixation is outside the norm. It has not yet been determined that the initial varus alignment was adequately addressed.
What makes you a good expert for this case?
25 yrs of experience as the evolution of total ankle replacement has occurred.
How often do you encounter cases similar to this one in your practice?
Not enough info to comment Would need to evaluate x-rays
Want to open a case or submit response?
Comments are accepted only from Orthopaedic Surgery - includes all subspecialties experts.