(b)(4).Concomitant medical products: unknown magnum head, unknown bimetric stem, and unknown taper adapter.Multiple reports were submitted along with this report 0001825034-2021-02874, 0001825034-2021-02875, and 0001825034-2021-02876.Revision notes state that the patient was revised due to loosening and a large pseudotumor was debrided.The femur had significant loosening and the surgeon had to do an osteotomy to remove the stem.Reported event was confirmed by review of medical records received.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.
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