Batch review performed on 24 september 2018; lot 165523: (b)(4) items manufactured and released on 29 november 2016.Expiration date:2021-11-20; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 14 september 2018; infection in cemented unicompartmental knee arthroplasty, 2 months after primary operation.Infection is a known possible adverse event following every surgery, including knee arthroplasty.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
|
Visual inspection performed by r&d product manager on 15 november 2018: visual inspection of the explanted cemented anatomical femoral component and full pe tibial component: revision surgery after 2 months from primary implantation due to infection.Residual cement can be noted on both the explanted components.One scratch can seen on the articular surface of the femoral component most likely caused during the attempt to explant the implant.Infection is a known possible adverse event following every surgery, including knee arthroplasty.From visual inspection, there is no reason to suspect that the cause may be linked to the implanted devices.
|