(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # 00-4349-040-11, glenosphere 40 mm, lot # unk or part number 00-4349-036-11, 01.04223-018, reverse screw, lot # unk, 01.4223-048, reverse screw, lot # unk, 01.04207.072, humeral stem, lot # unk, 01.4207.142, humeral stem, lot # unk, 01.04223.100, humeral shell, lot # unk, 01.04223.106, humeral shell, lot # unk, 01.4223.360, lot # unk, 01.04223.400, lot # unk.Event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06422.
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