(b)(4).Concomitant medical products: femoral head, catalog#: 650-0840, lot#: 2686076; acetabular shell, catalog#: 00620205820, lot#: 62585810; acetabular liner, catalog#: 00631005836, lot#: 62692445; bone screw, catalog#: 00625006540, lot#: 61126043; bone screw, catalog#: 00625006550, lot#: 60376941 & 60809033; bone screw ,catalog#: 00625006525, lot#: 61953465; bone screw, catalog#: 00625006530, lot#: 62483015.Reporting source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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