Batch review performed on 25 october 2023: lot 2212249: (b)(4) items manufactured and released on 31-aug-2022.Expiration date: 2027-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department postoperative tibial fracture was reported a few days after primary cemented uka (moto partial knee system).No information about the cause of the fracture are reported.We cannot say whether a traumatic event occured or the quality of the bone was poor.However, the tibial preparation may have weakened the bone.The x-ray images show a depression fracture of the medial tibial plateu not involving the implant which appears well positioned.The patient was revised with a sphere total knee implant and an augment.With the element at disposal, there is no reason to suspect a faulty device.
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