WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Pain (1994)
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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 and 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 august 2013 and may 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).Revision of metal components was performed for aseptic loosening and persistent pain in 2 cases.The first case showed subtle lucency at the posterior aspect of the talar component only on ct scan, but no change in component position.Talar component loosening was identified intraoperatively, though the tibial component remained well fixed.Isolated talar component revision with an inbone ii talar component was performed at 24 months postoperatively.In the second case, the tibial component was seen to subside into dorsiflexion by 7° on radiographs, and ct scan demonstrated subtle osteolysis adjacent to both the talar and tibial components.Intraoperatively both the talar and tibial components were found to be loose and were revised with inbone ii tibial and talar components at 22 months postoperatively.
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