(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00042, 0001822565-2021-00044, 0001822565-2021-00045, 0001822565-2021-00046, 0001822565-2021-00047, 0001822565-2021-00048.
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This follow-up report is being submitted to relay additional information.The returned product exhibits signs of repeated use and has one of each components 42527991001 and 42527991002, 1 and 2 disassembled/missing.The missing components were not returned.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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