(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42532006702, tibia, lot # 62331211; 42500606002, femur, lot # 62364751; 00111314001, bone cement, lot # 76404338; 00111314001, bone cement, lot # 76684363; 00111314001, bone cement, lot # 77584367; 00111314001, bone cement, lot # 76394338; 42540000032, poly patella, lot # 62268836; 42522400512, bearing, lot # 62488904.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02910, 3007963827-2018-00092, 0001822565-2018-02914, 0001822565-2018-02913, 0001822565-2018-02912, 0001822565-2019-04277.
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This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of medical records.Revision op notes demonstrated that the patient was revised due to aseptic loosening.During the revision, arthrofibrosis was noted.Burr and osteotomes were required for disimpaction of both the tibial and femoral components as they were not grossly loose.Osteo granules were placed in cavitary defect upon tibial stem removal.Bone loss classification of the tibia was aori type 2b.All product was removed.A review of the device history records did not identify any deviations or anomalies during manufacturing related to the reported event.A root cause was unable to be determined.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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