Reported event: an event regarding loosening involving a mets, distal femur replacement was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.A review of the provided x-rays by a clinical consultant indicated: clinical review: the implant in situ was for a mets distal femoral replacement, the date of insertion is unknown.The surgeon reported aseptic loosening of the femoral stem and the femur is shorter.The ct image provided shows that the femoral cavity was misaligned with the stem, caused bone remodelling at the tip of the stem, but the stem has not penetrated yet.There was massive radiolucency along the loosed stem with fragmentation of the cement mantle.The bone has undergone significant remodelling and resorption, especially on the medial side.In addition, the affected femur is 5cm shorter than the opposite femur.Therefore, the radiographic review can confirm the clinical report and reason for revision.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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