GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 17, 2026 · Event occurred Jul 7, 2026
Report 3005180920-2026-00754 · MDR key 25854831
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 3r - 12mm
Manufacturer
Medacta International SaModel number
02.12.E0312FRLot number
2247354
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Joint Laxity
- Implant Pain
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 17 JULY 2026 LOT. 2247354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2023. EXPIRATION DATE: 2028-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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.
Description of Event or Problem
REVISION SURGERY DUE TO ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT FROM A 12MM INSERT TO A 13MM AT HIS DISCRETION.