(b)(4).Concomitant medical products: bmet regenx pri tib tray 71 mm catalog#: 141273 lot#: 504530, biomet finned pri stem 40 mm catalog#: 141314 lot#: 063050, vanguard cr por fem-rt 60 catalog#: 183044 lot#: 860710, e1 vngd as tib brg 10x71 catalog#: ep-189060 lot#: 663740.Customer has indicated that the product will not be returned to zimmer biomet for investigation, because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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