Batch review performed on 06 october 2023.Lot 2108661:(b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-09-15.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 medical affairs deparment: a revision surgery was conducted 2 months after the first implant of a moto partial knee.No clinical infromation are reported about the patient.The reported reason for revision is implant failure due to poor bone quality (detected during a follow up check).We have only one projection x-ray available, where we can assess subsidence and probably a posterior migration of the tibial component.Among the causes of this kind of failure, there is certainly the poor quality of the bone (as declared in the report).However, with the information at hand it is diffcult to determine whether other causes occured (such as malpoisitioning, undesizing, trauma, intraoperative issues during the cementation phase.).We have no reason to suspect a malfunctioning device.The revision surgery provided the implant of a tka (gmk sphere) and it completed successfully.
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