(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Medical devices: part # unk, ulnar component, lot # unk; 00-1119-140-01, palacos lvg 1x40 single, lot # 75394316; 32-8105-025-01, cm pinbush replace.Kit smlreg, lot # 62354122.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 07063.
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