GMK Primary Total Knee System

Description of Event or Problem

Revision surgery after 5 months from the primary due to infection. The surgeon revised all the components to match those of the competitor.

Additional Manufacturer Narrative

Batch review performed on 23 July 2026 02.07.1204R GMK Tibial Tray Cemented Right S4 (K090988) Lot. 2517450: (b)(4) items manufactured and released on 29 September 2025. Expiration date: 12 September 2030. 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. 02.12.E0410FR GMK-SPHERE tibial insert E-Cross - Flex 4R - 10mm (K202022) Lot. 2520130: (b)(4) items manufactured and released on 29 August 2025. Expiration date: 31 July 2030. 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. 02.12.KA14R GMK Spherika femoral component S4+R Cemented (K211004) Lot. 2518172: (b)(4) items manufactured and released on 19 September 2025. Expiration date: 07 September 2030. 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. 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.