At about 3 years and 2 months from the primary, the patient came in reporting pain due to a loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray, insert, and femur to competitor components.The surgery was completed successfully.
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Batch review performed on 12 march 2024.Lot 2005035: (b)(4) items manufactured and released on 10-sept-2020.Expiration date: 2025-09-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Investigation performed by r&d project manager.Revision surgery of a gmk sphere implant after 3 years from primary due to tibia loosening.From investigation based on the pictures of the removed components, no residual cement can be noted on the distal surface of tibial baseplate.Residual cement still adherent to the component is visible on the internal surface of the femoral implant.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).Absence of cement is not an evidence of a faulty device.There is no evidence to suspect that the event is related to a faulty device.
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