Batch review performed on 08 september 2022: lot 2004507: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2025-07-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved.Batch review performed on 08 september 2022: moto partial knee 02.18.Tf4.Lm tibial tray fix cemented s4 lm (k162084) lot 2105879: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2026-07-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: few months after primary cemented uka, the patient reports pain and revision is required.Both components are mobilized, and according to the report there was no cement on the bone, while the metal parts were well embedded in cement.This may well be a cause for early mobilization, and in that case it should be related to a problem occurred during cementation, such as an expected delay between cement mixing and bone application, or unexpectedly high temperature in the operating room that made the cement cure faster than expected.No reason to suspect a faulty device at the origin of this problem.
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During a follow-up visit, the patient reported pain at the tibial component.At about 7 months after the primary, the revision surgery was performed and during the revision it was noted the loosening of both tibial and femoral components and that no cement was present on the bone of the patient.The surgeon revised successfully all components and implanted gmk sphere system.
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