Additional manufacturer narrative reported event: an event regarding loosening involving a jts, distal femur, femoral 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 jts distal femoral replacement which was inserted in 2015.The surgeon reported maximum extension and loosening of the stem.The ct image provided shows the radiolucent line between the cement mantle and femoral bone; the femoral stem was mal-aligned with the proximal femur in which the proximal femoral bone has moved in varus position.This is probably due to the loosening of the stem.The implant has been extended by 50 mm which has almost reached to its maximum capacity of 60 mm.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 11 dec 2015 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, 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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