(b)(4).Concomitant medical products: 10-104052, m2a taper cup, 254250; 11-163689, m2a taper carbon head, 404460; unknown stem, unknown part and lot.Report source (b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k042037.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon did not approve of the return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03465, 0001825034-2019-03467.
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