GMK Sphere Total Knee System

Description of Event or Problem

Revision surgery after 1 year and 3 months due to infection.The surgeon performed a washout and revised the knee.

Additional Manufacturer Narrative

Batch review performed on 17 July 2026 02.12.0413FR GMK-SPHERE Tibial Insert - Flex S4R - 13 mm (K140826) Lot. 2248034: (b)(4) items manufactured and released on 24 February 2023. Expiration date: 06 February 2028. 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.