An event regarding crack/fracture involving a restoration modular stem was reported.The event was confirmed based on review of the medical records by a clinical consultant.Device evaluation and results: not performed as product was not returned a review of the provided medical records and/or x-rays by a clinical consultant indicated: in this case there was a mechanical failure of a fully coated stem used to treat a periprosthetic fracture.There is no evidence of any patent related factors such as increased patient weight, young age or higher activity level.No clinical history of trauma was provided.Based on the single image, the femoral component was well-fixed distally and not proximally, creating a stress-riser.Cantilever bending forces caused the stem to give out.Mechanical failure of total hip implants has been described in the literature and is not common.Often an anatomic factor contributing to the failure can be identified.In this case, it could be the stem not getting fixation proximally.Without an examination of a retrieved implant, i cannot say that this event was implant related.The lot code should be checked in the database to ensure there were no other similar events.Although an unlikely cause, it would be worth confirming there was no traumatic event.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The reported stem fracture was confirmed based on review of the medical records by a clinical consultant.Clinician review indicated that there is no evidence of any patent related factors such as increased patient weight, young age or higher activity level.No clinical history of trauma was provided.Based on the single image, the femoral component was well-fixed distally and not proximally, creating a stress-riser.Cantilever bending forces caused the stem to give out.Mechanical failure of total hip implants has been described in the literature and is not common.Often an anatomic factor contributing to the failure can be identified.In this case, it could be the stem not getting fixation proximally.The root cause of the event could not be determined because insufficient information was provided.Additional information, including implant evaluation and confirming that there was no traumatic event is required to further investigate this event.If further information becomes available or the product is returned, this investigation will be re-opened.
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