(b)(4).Medical product: catalog #: 110031399, mini humeral tray standard thickness, lot # 64396704; catalog #: 110031418, bearing standard 36 mm diameter, lot # 64343765; catalog #: 113625, comprehensive mini primary stem, lot # 434380; catalog #: 115316, comprehensive reverse glenosphere 36mm, lot # 829820.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2021-00954.
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