WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Mechanical Problem (1384)
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Patient Problem
Loss of Range of Motion (2032)
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Event Type
Injury
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Manufacturer Narrative
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Literature citation: christopher e.Gross, md et al.Surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty.Foot & ankle specialist.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 by gross et al in "surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty" that in a retrospective study in which several implants from various manufacturers including inbone, it was found that 75 patients (7.5%) required either open (n = 49) or arthroscopic debridement for impingement after tar; 44 patients had >12 months of follow-up, with a follow-up of 26.5 months after their debridement procedure.The mean time to the debridement procedure for all prostheses was 9.3 months, with an average of 21.8 months with inbone.Of the patients with more than 1 year's follow-up from their debridement, 84.1% were asymptomatic; 9 patients (20.4%) had repeat operations after their debridement procedure.Of these, 5 patients required a repeat debridement of their medial or lateral gutters for a failure rate of 11.4%.
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Search Alerts/Recalls
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