GMK Hinge Total Knee System

Description of Event or Problem

The patient had primary left knee surgery with competitor products. On (b)(6) 2024, the patient was revised to Medacta GMK-Hinge implants. Presently, on (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout, removed all implants and placed a cemented antibiotic spacer with external fixation. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 21 July 2026 GMK-HINGE 02.09.4003L GMK-HINGE Tibial Tray - 3L (K130299) Lot. 2400767: (b)(4) items manufactured and released on 18-Mar-2024. Expiration date: 04-Mar-2029. No anomalies found related to the problem. To date, all items of the same lot have been sold, with no similar reported events during the period of review. GMK-HINGE 02.09.0326UCH GMK-HINGE - UC Tibial Insert - Size3 - 26 mm (K172347) Lot. 2008821: (b)(4) items manufactured and released on 26-Feb-2021. Expiration date: 16-Feb-2026. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review. GMK-HINGE 02.09.2603L GMK-HINGE Femoral Component L - Size3 (K130299) Lot. 2340875: (b)(4) items manufactured and released on 11-Apr-2024. Expiration date: 11-Mar-2029. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review. Root cause: Infection is a known possible complication of any surgery. Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.