Clinical evaluation performed by medical affairs department.One year after a complex case of revision tka the cemented components become loose.The low-quality pictures included in the report show very low quality bones, possibly affected by some sort of osteomalacia, not mentioned in the report - a situation that certainly makes the fixation of a large constrained prosthesis very challenging.We can only hypothesize that the low quality of the bone made fixation impossible, because the implant position, albeit very challenging, appears correct.Batch review performed on 21 november 2022: lot 2101290: (b)(4) items manufactured and released on 09-june-2021.Expiration date: 2026-05-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Other component involved: gmk-hinge 02.09.2604r femoral component size 4 r (k130299) lot 1904680: (b)(4) items manufactured and released on 25-sept-2019.Expiration date: 2024-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
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