(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00384, 0001822565-2024-00385, 0001822565-2024-00386, 0001822565-2024-00387, 0001822565-2024-00389, 0001822565-2024-00390, 0001822565-2024-00392, 0001822565-2024-00394 g2: foreign: italy it is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
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It was further reported that the patient experienced a tibia and fibula fracture and underwent a reduction and fixation.Subsequently, the patient underwent a scheduled procedure for removal of a tibial and fibula plate and screws approximately 18 months post initial procedure.The patient was not experiencing any adverse events.As indicated, the procedure was a standard of care removal and completed without complication.
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