(b)(4).Patient date of birth: (b)(6) 1951.(b)(4).Concomitant medical products: partial femur cemented size 5 right medial cat: 42558000502 lot: 63485124, partial tibial cemented size f right medial cat: 42538000602 lot: 63463516.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04002, 0001822565-2018-04011, 0001822565-2018-04012.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.
|