GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 8, 2026 · Event occurred Jun 17, 2026
Report 3005180920-2026-00649 · MDR key 25747719
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 3r - 12mm
Manufacturer
Medacta International SaModel number
02.12.E0312FRLot number
2507478
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Female
- Joint Laxity
- Implant Pain
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 18 JUN 2026 LOT 2507478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2025. EXPIRATION DATE: 2030-AUG-26. 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 LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE 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
AT4 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE FLEX 3R - 12MM INSERT TO A FLEX 3R - 20MM AFTER TRIALING A 17MM AND FINDING THE STABILITY UNSATISFACTORY. THE SURGERY WAS COMPLETED SUCCESSFULLY.