(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-02789; 0001825034-2022-02790.Initial surgery took place in 2015.Medical product: unknown vanguard femoral; unknown vanguard tibial tray.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that a patient was revised due to pain, instability, stiffness, and laxity.During the revision, the tibia, femur, and art surface were replaced.The operative report states patient had diffuse laxity of the medical side of the knee and very soft bone.Cancellous bone loss in the tibia was also noted.Attempts to obtain additional information have been made; however, no more information is available.
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