Revision surgery performed about 1 year and 4 months after the primary surgery due to pain and suspected tibial tray loosening.During the revision surgery, the implants appeared not loose and something else must have been causing pain, but the reason remains unknown.Gmk-sphere with extension stem implanted.
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Batch review performed on 21 nov 2023: lot 2012098: (b)(4) manufactured and released on 01-feb-2021.Expiration date: 2026-jan-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Preliminary investigation performed by r&d project manager: revision surgery of a moto implant after 1 year and 4 months from primary implantation due to pain and suspected tibial loosening.During revision surgery, the tibial was found not loosened, so the cause of pain should have been something different.From the picture sent of the explanted components, sent for investigation, it is not possibile to note any anomalies.From preliminary investigation, there is no evidence or reason to suspect that the event is related to a faulty device.Additional implants involved, batch review performed on 21 nov 2023: moto partial knee 02.18.If3.08.Lm tibial insert fix s3 lm - 8mm (k162084) lot 1910080: (b)(4)manufactured and released on 17-dec-2019.Expiration date: 2024-dec-03.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Moto partial knee 02.18.Tf3.Lm tibial tray fix cemented s3 lm (k162084) lot 2009937: (b)(4)manufactured and released on 01-feb-2021.Expiration date: 2026-jan-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
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