WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Missing Information (4053)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Literature citation: murray penner, md et al.The infinity total ankle system early clinical results with 2- to 4-year follow-up.Foot & ankle specialist.2018; volume 11: pages 1-7.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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Allegedly, it was reported in "the infinity total ankle system early clinical results with 2- to 4-year follow-up" that 67 consecutive patients who underwent primary total ankle arthroplasty (taa) with the infinity system at 2 north american sites between (b)(6) 2013 and (b)(6) 2015 were reviewed in a prospective, observational study.Demographic, radiographic, and functional outcome data were collected preoperatively, at 6 to 12 months postoperatively, and annually thereafter.Results.The overall implant survival rate was 97% (65 of 67 implants) at a mean follow up of 35.4 months (27 to 47 months).Patient underwent reoperation for hardware removal.
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