(b)(4).Concomitant medical products: catalog number: 163661, lot number: unknown, brand name: cocr modular head.Catalog number: 104154, lot number: unknown, brand name: ringloc shell.Catalog number: 162342, lot number: unknown, brand name: bi-metric stem.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2019-00515.Two x-rays were provided which were further assessed and the report stated that there was a superior dislocation of the femoral head.Asymmetric positioning of the femoral head suggesting polyethylene wear.No other anomalies were noted.Reported event was confirmed by review of x-rays provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Device not returned for evaluation.
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