(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded by hospital.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant 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.Udi #: (01) 0 0880304 54420 8 (17) 290304 (10) 6497857.Concomitant medical products: item # unknown/unknown head/ lot # unknown, item # unknown/ unknown liner/ /lot # unknown, item # unknown/ unknown stem/ /lot # unknown.
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