Batch review performed on 12 april 2022.Lot 2007868: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-10-11.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d manager: revision surgery of a moto medial uni knee after 1 year and 3 months from primary implantation due to femoral loosening.Visual inspection of the explanted femoral component, tibial component and tibial insert sent back for investigation.No residual cement can be seen in the internal surface of the femoral component.Cement on the femoral remained probably adherent to the bone.This could be a sign of poor interdigitation between cement and implant.Residual cement can be seen on the distal surface of the tibial baseplate.Many factors could had played a role in the lack of interdigitation between implant and cement, such as cemenentation process, temperature, wetting of the implant; those are most likely not implant related.No further elements that can be considered relevant for the event can be noted.From visual inspection there is no evidence that the event is related to a faulty device.
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