Batch review performed on 22 november 2018.Lot 155449: (b)(4) items manufactured and released on 12 november 2015.Expiration date: 2020-10-28.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.Additional component revised: gmk-uni 02.08.Ct2.08.Rmll tibial component full pe #2 8mm rm-ll (not marketed in us) lot 154878: (b)(4) items manufactured and released on 12 november 2015.Expiration date: 2020-08-17.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.Preliminary investigation performed by r&d knee manager: revision surgery after 2 years from primary surgery for allergy and sudden deviation of implant set-up.Some residual cement can be seen on the internal surface of the femoral component and on the distal surface of the full pr insert.Some scratches are present both on the femur and the tibial components most likely caused during the attempt to explant the implants.There is no reason to suppose the event is related to a faulty device.Visual inspection performed by r&d knee manager: visual inspection confirms what already stated during preliminary investigation.Some residual cement can be seen on the internal surface of the femoral component and on the distal surface of the full pe insert.Some scratches are present both on the femur and the tibial components most likely caused during the attempt to explant the implants.Articular surface of the tibia component regularly worn out after 2 years from primary implantation.There is no reason to suppose the event is related to a faulty device.Clinical evaluation performed by medical affairs director: 2 years after primary cemented uka the patient was revised.From the radiographs, a progression of the disease can be surmised, which is probably the main reason for transforming the uka to a tka.According to report, the patient suffered from allergy during the first 6 months, but this problem must have been overcome.It is impossible for us to tell whether the suboptimal orientation of the components which is visible in the pre-revision xrays is due to allergic reaction.However, there is no reason to suspect that a faulty device is responsible.
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