An event regarding disassociation involving a mets distal femur replacement, shaft 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 mets distal femoral replacement, the date of insertion was in 2012.The surgeon reported a failure of the taper junction.The ct scan provided shows that the femoral implant has been rotated which indicate that the taper junction between the femoral shaft within the femoral component has disengaged.However, this disengagement of the taper junction can not be observed radiographically.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch information was not provided.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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