Non bone interfacing device reported in error.Updated information for unknown bone interfacing device (femoral stem) provided corrections to: d1, d2, d4, d6, g5, h4 and h6 codes an event regarding femoral and tibial loosening as well as a fracture of the femoral stem involving an unknown stem component was reported.The event was confirmed based on clinician review of the x-rays provided.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem; need revision operative report and examination of explanted components.-device history review: not performed as the lot id was not provided.-complaint history review: not performed as the lot id was not provided.Conclusions: review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including revision operative report and examination of explanted components 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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