Reported event: an event regarding malposition involving a mig distal femur, tibial stem was reported.The event was confirmed by x-ray review.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 a left mig distal femoral replacement which was inserted on (b)(6) 2014.Clinical reported that the patient has pain.The x-rays provided shows that both femoral and tibial stems are well fixed but the tibial stem is misaligned inside the canal and the knee joint has excessive extension, which might cause the pain in the knee joint.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicate 1 devices was manufactured and accepted into final stock on 19 jun 2014 with no reported discrepancies.Complaint history review: there have been no other events.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, 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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