Batch review performed on 20-dec-2023 lot 2245240: 25 items manufactured and released on 16-mar-2023.Expiration date: 2028-02-26.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.Additional device involved batch review performed on 20-dec-2023 gmk-revision 02.07.0684l revision fixed tibial tray cemented size 4 l (k123721) lot 2302319: 24 items manufactured and released on 26-jul-2023.Expiration date: 2028-07-12.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.Clinical evaluation performed by medacta medical affairs director: dissociation of tibial insert in a very complex case of revision tka, 2 months after index surgery.The patient is very heavy.We assume that the low quality radiographs labelled as "supine" were taken immediately postoperatively.They show that the insert fixation screw did not reach the position of full insertion: this may be due to technical difficulties encountered when operating on such a large patient.The incorrect position of the screw meant that the support of the insert was limited and therefore, in a pivotal movement, it may have unclipped.We cannot tell if the initial clipping could be carried out completely because it does not show on the radiographs, but in any case the main cause that we may assume for the dissociation is the incomplete insertion of the insert locking screw.Analysis perfomed by medacta knee r&d project manager: tibial insert dissociation after 2 months from revision tka.The provided pictures show a sc peg clearly not ingaged into the tibial tray.Assuming that the x-rays were taken immediately post-op it is possible to suspect that the sc peg was not fully inserted and screwed into the tibial tray.There are no confirmation that the dynamometric torque wrench was used at the time of the revision surgery.The sc peg is intended to support the tibial insert cam against the stress that occurs in the flexion-extension movement.We can assert that the main reason of the insert dissociation is the not effective or the lack of sc peg fixation into the tibial tray.Based on the available information it is not possible to suspect that the complaint is related to a faulty device.
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