GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 16, 2026 · Event occurred Jul 8, 2026
Report 3005180920-2026-00736 · MDR key 25838708
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 4r - 17mm
Manufacturer
Medacta International SaModel number
02.12.E0417FRLot number
2245468
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
83 YR · Female
- Pain
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 15 JULY 2026 02.12. E0417FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 17MM (K202022) LOT. 2245468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2023. EXPIRATION DATE: 30 JANUARY 2028. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.
Description of Event or Problem
REVISION SURGERY AFTER 7 MONTHS FROM MEDACTA PRIMARY SURGERY DUE TO ANTERIOR KNEE PAIN. THE SURGEON REVISED THE PATELLA AND UPSIZED THE INSERT.