Reported event: an event regarding wear involving a patient specific, proximal tibial replacement, bushing was reported.The event was not 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 proximal tibial replacement which was inserted in (b)(6) 2007.The surgeon reported poly wear of the knee joint.The x-ray images provided show that the femoral implant is aligned with the tibial component.However, in the front view of the image, the axle has backed out laterally which may suggest wear of the poly bushes.Therefore, the radiographic review can confirm the clinical report and the reason for revision.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 event.Pi (b)(6).Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes, 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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