(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825304-2022-02254, 0001825034-2022-02255.The device will not be returned for analysis, as the location of the device is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
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It was reported that the patient underwent a left hip revision approximately 17 years post implantation due to pain, elevated metal ions, metallosis, osteolysis, leg length discrepancy, decreased activity daily living, and pseudotumor.During the procedure it was noted that there was extensive soft tissue damage, osteolysis, resorption of proximal femur, muscle damage, large pseudotumor, metallosis, and extensive bone loss.All components were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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(b)(4).This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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