WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Migration (4003)
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Patient Problems
Cyst(s) (1800); Bone Fracture(s) (1870); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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Literature citation: guilherme h.Saito, et al.Short-term complications, reoperations, and radiographic outcomes of a new fixed-bearing total ankle arthroplasty.Foot and ankle international.2018; volume: 00 page(s)0 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, per saito et al in "short-term complications, reoperations, and radiographic outcomes of a new fixed-bearing total ankle arthroplasty" 64 patients underwent a total ankle replacement surgery.It was reported that 5 patients were treated for gutter impingement, 4 patients were treated for tibial subsidence, 1 patient treated for talar subsidence, 2 patients treated for post-op stress fracture, 1 patient treated for a tibial cyst, 1 patient was treated for hindfoot malalignment, 1 patient treated for superficial infection, and 1 patient treated for delayed wound healing.The average age of the patients was 61 (range of 31-81) and the avg follow up was 24.5 months (range 18-39).
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Search Alerts/Recalls
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