American orthopaedic foot & ankle society (2018) published "single-surgeon experience and complications of a fixed-bearing total ankle arthroplasty".This study aimed to retrospectively evaluate intra- and postoperative complications in 96 patients (104 total ankle arthroplasty) from a consecutive, single-surgeon population of primary salto talaris arthroplasty procedures, using radiographic analysis and medical records review to identify complications and the glazebrook classification system to categorize complications.Method: medical records from index procedure to latest follow-up of primary taa were reviewed.Complications were categorized according to the glazebrook classification; additional complications were documented.Concurrent procedures were recorded, and radiographs were analyzed for alignment, subsidence, and cyst formation.Time to complication onset and learning curve analyses were performed.One hundred four salto talaris taa prostheses (96 patients), with an average follow-up of 46 months, were included.Results: thirty-five complications were identified in 32 ankles with a 34% complication rate, resulting in 11 reoperations (5 taa revisions).Technical error (n = 12), wound healing (n = 9), and aseptic loosening (n = 4) were the most common complications, and there were no statistically significant differences in demographics or follow-up duration between cases with versus without complications.In both the cohorts with and without complications, there were moderate, negative correlations between radiographically observed keel osteopenia and lucency; also, in the complication cohort, a weak, positive correlation between subsidence and lucency was found.Conclusion: the 2-component salto talaris taa was an existing tool for the management of advanced ankle arthritis in a range of potential ankle arthroplasty candidates; however, few clinical reports and analyses of this specific implant existed.Two learning curve analyses highlighted the significance of technical expertise and annual volume of taa cases on complication rates.Implant survivorship and reoperation rate in this series were similar to previously reported early-term outcomes.The glazebrook classification of complication types in taa was applied to this series.A statistically significant correlation was found between radiographically observed lucency and "keel osteopenia" in both the cohorts, with and without complications.It may be possible to identify patients who are at increased risk for impending taa failure by documenting radiographic periprosthetic lucency, osteolysis, and cyst formation, thus allowing the clinician opportunities for more vigilant observation and follow-up.Event description for subject# 99 patient's age and gender - (b)(6) male; bmi - 26.5; preoperative diagnosis - [left] rheumatoid arthritis, fixed planovalgus deformity, hindfoot/midfoot malunion; medical history - rheumatoid arthritis, myocardial infarction; operative history - right subtalar arthrodesis, left subtalar arthrodesis, right hip surgery, bilateral knee arthroplasty, right ankle total ankle arthroplasty; concomitant procedure - calcaneal osteotomy; tendo-achilles lengthening; removal of implants from previous surgery; midfoot/hindfoot osteotomy and fusion; total follow-up (months) - 22; complication type - nonunion; (contralateral side: wound healing [subject 91]); complication onset (months) - 3; complication details - incomplete union of midfoot osteotomy site noted on x-ray; complication treatment - revision triple arthrodesis with treatment of nonunion, removal ankle implants; complication rating - high.
|
The complaint device was not returned for evaluation.No lot information was provided; therefore, no dhr review can be performed.As no parts were returned, no failure analysis can be performed.The root cause for the reported event remains unknown.Attempts for additional information and product return have been unsuccessful to date.
|