(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-02788, 0001825034-2022-02789.Implant date: initial surgery took place in 2015.Concomitant medical products: medical product.Unknown vanguard articular surface.Unknown vanguard femoral.Device evaluated by mfr: 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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