(b)(4).D10: medical product: van ps open intl fem-lt 65: catalog#183128, lot#324010; vanguard fem pegs set 2: catalog#183099, lot#ni; biomet offset tibial tray 75mm: catalog#141484, lot#ni; offset tib tray 2.5mm adaptor: catalog#141490, lot#ni; bmt splined knee stm 14x80: catalog#141614, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2024-00070; 0001825034-2024-00072.The customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
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