(b)(4).Concomitant medical devices: 00801804003 femoral head 61123356; 00630506040 liner 61154845; item #: unknown, unknown cup lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03800, 0002648920 - 2021 - 00007.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) 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.Visual evaluation of the head identified the following: there was abundant corrosion debris in the taper.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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