GMK Hinge Total Knee System

Description of Event or Problem

About 2 years and 3 months post GMK-Hinge primary surgery, the femur is found dislocated, the tibial insert dissociated, and the insert screw broken. The plan was to revise the insert but since the broken part of the screw could not be removed from the tibial tray (the top part of the screw was removed), the surgeon decided to cement the insert on the tibial tray to act as a spacer and wait for the wound to heal. A total revision surgery will be performed at a later date. Surgeon believes that the patient developed further laxity post-op causing the hinge mechanism to dislocate and eventually fatiguing the screw.

Additional Manufacturer Narrative

Clinical evaluation performed by Medical Affairs Department Approximately 2 years and 3 months after the implantation of a left GMK-HINGE knee prosthesis, the patient experienced dislocation/disassembly of the hinge mechanism associated with fracture of the insert locking screw. The available X-ray images clearly confirm the occurrence. The event required an unplanned temporary revision and will require definitive revision to a distal femoral replacement. It is difficult to determine the root cause of this failure, but the surgeon reported a progressive soft-tissue laxity that could have caused repeated pistoning and fatigue loading of the screw. This could be a plausible mechanism, consistent with the screw fracture and the consequent implant dissociation. However, this mechanism has not been objectively demonstrated, so definitive conslusion cannot be made. Batch review performed on 16 July 2026 GMK-HINGE 02.09.0320H GMK-HINGE Tibial Insert - Size3 - 20 mm (K130299) Lot 2105025: (b)(4) items manufactured and released on 23-Jun-2021. Expiration date: 08-Jun-2026. 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. GMK-HINGE 02.09.4003L GMK-HINGE Tibial Tray - 3L (K130299) Lot 2344762: (b)(4) items manufactured and released on 20-Feb-2024. Expiration date: 07-Feb-2029. 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. GMK-HINGE 02.09.4003L GMK-HINGE Femoral Component L - Size4 (K130299) Lot 2311766: (b)(4) items manufactured and released on 12-Sep-2023. Expiration date: 26-Aug-2028. No anomalies found related to the problem. To date, all items of the same lot have been sold with no similar reported event during the period of review. Root cause: Based on the information available, no definitive root cause can be established. The reported progressive soft-tissue laxity may have resulted in fatigue loading of the insert locking screw, representing a plausible explanation for the observed screw fracture and subsequent hinge dissociation, however specific factors involved cannot be confirmed. The device history record review does not indicate any potentially related manufacturing issue.