InjuryJWH
GMK Sphere Total Knee System
Received Jul 27, 2026 · Event occurred Mar 20, 2026
Report 3005180920-2026-00784 · MDR key 50005851
Device
Generic name
Gmk-sphere Tibial Insert
Manufacturer
Medacta International SaProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Female
- Joint Laxity
Narrative
Description of Event or Problem
Primary surgery performed on the (b)(6) 2024. Revision surgery performed on the (b)(6) 2026 due to knee laxity. Only the liner was revised.
Additional Manufacturer Narrative
No analysis could be performed since lot numbers are unknown and devices are not available for inspection. 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.