Batch review performed on 17 october 2023 lot 2219899: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-09-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 october 2023.Moto partial knee 02.18.If4.08.Llrl tibial insert fix s4 - lateral - 8mm (k183029) lot 2215654: 16 items manufactured and released on 10-oct-2022.Expiration date: 2027-09-22.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs manager on the (b)(6) 2023: a reoperation was conducted 1 year after the primary implant of a bi-monocompartmental knee arthroplasty (moto medial and moto lateral).The reported casuse is a purulent arthritis, for which a scraping procedure was conducted.Infection is a possible complication of knee surgery and a delayed onset (such in this case) is widely described in the literature.On the available x-rays, there are doubtful signs of bony alteration in the proximal tibia (especially on the lateral side).However the surgeon evaluated the implant stable, changing only the inserts.We have no reason to suspect a defective or malfunctioning device.
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