Customer has not indicated whether or not the product will 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.(b)(4).Concomitant medical product - biomet humeral tray, catalog#: 115370 lot#: 648630; biomet baseplate, catalog #: 010000589 lot # 357480; biomet mini humeral stem, catalog#: 113631 lot#: 253100; biomet humeral bearing, catalog#: xl-115363 lot#: 418390; biomet central screw, catalog#: 115395 lot# 161960; biomet fixed locking screw, catalog#: 180550 lot#: 6192920; biomet fixed locking screw, catalog#: 180551 lot#: 863450; biomet fixed locking screw, catalog#: 180552 lot#: 294240.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-04698-1).
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