(b)(6).Date of event - unknown date approximately one (1) week prior to revision, and approximately one (1) week after primary procedure.Implant date - unknown date approximately one (1) week prior to revision.Concomitant medical product- dvr crosslock plate catalog#: 131822060 lot#: sbmo68387; non locking screw catalog#: 131227214 lot#: unk; smooth locking peg catalog#: 131227018, lot#: unk, qty: 4; smooth locking peg catalog#: 131227016, lot#: unk, qty: 2; non-locking screw catalog#: 131227216, lot# unk, qty: 3.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06134, 0001825034-2017-06137, 0001825034-2017-06136, 0001825034-2017-06267, 0001825034-2017-06131, 0001825034-2017-06265, 0001825034-2017-06263, 0001825034-2017-06262, 0001825034-2017-06261, 0001825034-2017-06260.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon has retained the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It is reported that the patient initially underwent an open reduction internal fixation left wrist procedure.Approximately one (1) week post op the patient complained of extreme pain.Subsequently, two (2) weeks post op the patient underwent a revision surgery to replace all products, as the surgeon determined that the initial placement of the products was not ideal.
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This follow-up report is being submitted to relay additional information.Exact initial and revision surgery dates are unknown.However, it is known that the revision surgery occurred two (2) weeks post op of the initial procedure.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.
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