(b)(4).Concomitant medical products: item# unknown, unknown liner, lot# unknown; item# 157444, unknown head, lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was confirmed by review of xrays which indicated the acetabular component was affixed by surgical screws, one of which slightly traverses the medial wall of the acetabulum.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 as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05070- 1, 0001825034 - 2018 -05072 -1.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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