This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive reverse shoulder humeral tray with locking ring, catalog#: 115370, lot #: 327330.Arcom xl humeral bearing, catalog#: xl-115363, lot#: 935090.Comprehensive reverse shoulder glenosphere, catalog#: 115310, lot#: 455910.Comprehensive locking screw, catalog#: 180550, lot#: 131120.Comprehensive locking screw: catalog#: 180550, lot#: 494290.Comprehensive locking screw, catalog#: 180550, lot#: 211660.Comprehensive locking screw, catalog#: 180551, lot#: 772110.Comprehensive reverse central screw, catalog#: 115394, lot#: 485450.Comprehensive primary mini stem: catalog#: 113629, lot#: 392260.Comprehensive reverse baseplate + adapter, catalog#: 010000589, lot#: 206570.Comprehensive reverse drill, catalog#: 405889, lot#: 873170.Comprehensive reverse drill, catalog#: 405883, lot#: 432500.Comprehensive reverse shoulder steinmann pin, catalog#: 405800, lot#: 820130.Steinmann pin, catalog#: 406669, lot#: 063830.Reported event was unable to be confirmed due to limited information received from the customer.The locking ring from item number 115370, lot number 327330 was returned and item number 106021, lot number 684850 was discarded.Device history record (dhr) was reviewed and no discrepancies 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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It was reported that during a total shoulder arthroplasty, two locking rings were damaged intraoperatively while trying to assemble the humeral bearing to the tray.In the first attempt, the assembly tool was not used, however, on the second attempt with the replacement locking ring the tool was used.In both cases, the locking ring bent.No complications or delays reported.A new tray was opened and utilized to complete the procedure.No further information made available at this time.
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