(b)(4).Concomitant medical products: unknown stem, unknown hg cup, unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02105, 0001822565-2019-02147.Radiograph was provided and reviewed by a health care professional.Review of the available records identified eccentric position of the femoral head within acetabular cup reflecting advanced poly wear.Multiple foci of abnormal radiolucency consistent with osteolysis of the femoral component and at multiple areas along acetabular component were present.No further evaluation was possible with the images provided.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 remains implanted in the patient.
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