(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00778, 0001822565-2024-00779, 0001822565-2024-00780.D10: unknown stem; unknown head; unknown liner.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint is unable to be confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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.
|