Batch review performed on 10 july 2023: lot 2112437: (b)(4) items manufactured and released on 18-oct-2021.Expiration date: 2026-10-04.No anomalies found related to the problem.To date, 142 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved batch review performed on (b)(4) 2023.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot 2109864: (b)(4) items manufactured and released on 16-nov-2021.Expiration date: 2026-11-16.No anomalies found related to the problem.To date, 97 items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot 2110987: (b)(4) items manufactured and released on 05-oct-2021.Expiration date: 2026-09-21.No anomalies found related to the problem.To date, 47 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation: a revision surgery was performed 1,5 year after the first implant of a gmk sphere without resurfacing patella, using myknee instruments.The patient complained of anterior knee pain and joint stiffness (with maximum flexion at 20°).From the available x ray images, we can assess a mild subsidence of the tibial tray medially and anteriorly and no loosening.Also, we can observe a patella baja that may be accounted among the causes of anterior knee pain and restricted range of motion.We have no reason to suspect a defective or malfunctioning device.The revision surgery provided the implant of a gmk revision with resurfacing patella.
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