(b)(4).Concomitant products - catalog #: unknown, unknown finn bearing, lot # unknown; catalog #: unknown, unknown finn stem, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.The device history record was unable to be reviewed due to no lot or item number being provided root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.External radiologist reviewed provided x-rays and noted that there is extensive osteolysis and abnormal lucency along the tibial component and stem component shows valgus angulation.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 event, please see associated reports: 0001825034-2018-04473, 0001822565-2018-03966.Remains implanted.
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