(b)(4).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02643 - 02645 and 0001825034-2017-02647 - 02469; 0001825034-2016-04993 - 04996.
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This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive reverse shoulder glenosphere, catalog#: 115323, lot#: 555070; comprehensive reverse shoulder humeral tray, catalog#: 115370, lot#: 744590; versa-dial shoulder system comprehensive standard adaptor, catalog#: 118001, lot#: 543490; comprehensive reverse shoulder humeral bearing, catalog#: xl-115367, lot#: 970780; comprehensive reverse shoulder central screw, catalog#: 115385, lot#: 732670; fixed locking screw, catalog#: 180503, lot#: 721310; fixed locking screw, catalog#: 180505, lot#: 448010; fixed locking screw, catalog#: 180501, lot#: 491850; comprehensive shoulder primary stem, catalog#: 113653, lot#: 464950.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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