(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.Concomitant products: 010000938, g7 hi-wall liner, 3955844; 650-0661, delta ceramic femoral head, 2016110487; 51-111130, taperloc type1 bonemaster stem, 3665496.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k121874.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06840, 0001825034 - 2017 - 06842.
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