Reported event: an event regarding rebushing involving a patient specific, distal femoral replacement, bushing was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for patient specific distal femoral replacement which was inserted on (b)(6) 2000.The surgeon reported bush bearing failure.The ct image provided shows that the femoral component is in line with the tibial component.However, the circlip was backed out laterally which indicating that the knee bushing fixation was disengaged.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, additional x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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