Batch review performed on 28 july 2022: lot 1909605: 52 items manufactured and released on 29-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, 51 items of the same lot have been sold with another similar reported event during the period of review.Additional device involved batch review performed on 28 july 2022 gmk-sphere 02.12.0022r femoral component sphere cemented size 2+ r (k140826) lot 2003245: 60 items manufactured and released on 08-june-2020.Expiration date: 2025-05-28.No anomalies found related to the problem.To date, 56 items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by medacta r&d knee project mananger: revision surgery of a cemented gmk gmk sphere implant after around 2 years from implantation due to tibial aseptic loosening.During revision surgery, it was discovered that also the femoral component was loose.From visual inspection of the removed femoral component sent back for investigation (tibia not available), we can notice that some cement still adheres to the postero-medial side of the component, close to the chamfer.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).The lack of cement adhering to the device is not evidence of a faulty device.No other elements relevant to the event can be noted from visual inspection.Clinical evaluation performed by medacta medical affairs director: revision of a cemented tka at 2 years from index surgery.Both femoral and tibial components were found thoroughly detached from the cement mantle, which suggests that some incident happened during cementation process, such as an unexpected or unperceived delay in placing the cement over the metallic component, or, more unlikely, that the components were wet when cement was applied on them.We know that the above-mentioned factors are determinant in making cement interdigitation with the metal surface almost non-existing.The visual inspection did not reveal any defect in the component surface.
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