Reported event: an event regarding re-bushing involving a patient specific, proximal tibial replacement, circlip was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: the implant in situ was for proximal tibial replacement which was inserted on (b)(6) 2013.The surgeon requested rebushing of the component.The x-ray image provided shows that the implant is in good fixation and alignment, and not abnormal for the knee joint.However, considering the component was 9 years in situ, normal wear and tear are expected so that rebushing of the component can be justified.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been 1 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, pathology reports, progress notes, 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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