(b)(4).D10 - medical product: trabecular metal cruciate retaining monoblock tibial component catalog # 00588604510, lot # 61554937.G2: australia.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565 - 2023 - 03032 h3 other text : remains implanted.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.H6: suggested component code: mechanical g4-femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates that left total knee arthroplasty with possible evidence of osteolysis and nondisplaced upper pole patellar fracture.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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