An event regarding patella subluxation and a insert exchange involving a triathlon insert component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: review by a clinical consultant suggested that "there is no evidence that the patella maltracking on the left total knee arthroplasty, which responded to a soft tissue repair, was the result of factors of faulty component design, manufacturing or materials." device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: not performed because no product specific failure mode was reported.Conclusions: review by a clinical consultant suggested that "there is no evidence that the patella maltracking on the left total knee arthroplasty, which responded to a soft tissue repair, was the result of factors of faulty component design, manufacturing or materials." no further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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