(b)(4).This is a combined initial and final mdr report.Concomitant medical products: unknown oxford bearing component, catalog #: unknown, lot #: unknown; unknown oxford femoral component, catalog #:unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00100, 3002806535-2020-00101.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as the item number and lot number is unknown.A review of the complaint database could not be performed as item number is unavailable.Without the opportunity to examine the complaint product and without adequate information received regarding the event, the root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.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.
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