GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 9, 2026 · Event occurred Jun 25, 2026
Report 3005180920-2026-00683 · MDR key 25763517
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 4l - 10mm
Manufacturer
Medacta International SaModel number
02.12.E0410FLLot number
2418498
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Joint Laxity
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 1 JULY 2026: LOT 2418498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2024. EXPIRATION DATE: 21-AUG-2029. 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: THE SURGEON REVISED THE LINER HEIGHT TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem
THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 11 MONTHS FROM PRIMARY SURGERY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 10MM TO A GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 12MM FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.