(b)(4).Concomitant devices: zimmer unicompartmental knee articular surface size 4 11mm catalog #: 00584202411 lot #: 61443855, zimmer unicompartmental knee high flex precoat femoral component catalog #: 00584201602 lot #: 61928542, headed screw 48mm catalog #: 00579104100 lot #: 62208598, headed screw 33mm catalog #: 00579104400 lot #: 62203456.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Per package insert for unicompartmental knees, pain, noise, and limited physical activity are known potential adverse effects associated with the surgical procedure.However, 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.0001822565-2019-00999, 0001822565-2019-04800.
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