GMK Sphere Total Knee System
Received Jul 27, 2026 · Event occurred Jul 13, 2026
Report 3005180920-2026-00778 · MDR key 50005868
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 3l - 11mm
Manufacturer
Medacta International SaModel number
02.12.E0311FLLot number
2002475
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Female
- Joint Laxity
Narrative
Description of Event or Problem
At about 1 year 11 months after the primary, the patient came in presenting knee instability. The surgeon revised the insert 11mm to 14mm insert for stability. The surgery was completed successfully. Several months prior to this revision, the patient fractured her ankle and dislocated her patella.
Additional Manufacturer Narrative
Batch review performed on 20 July 2026 Lot 2002475: (b)(4) items manufactured and released on 14-July-2020. Expiration date: 2025-07-02. 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. Root cause: The surgeon revised liner height, which is a common practice to restore the joint stability. There is no indication that any potential issue with the device may have caused or contributed to the event.