GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 1, 2026 · Event occurred Jun 9, 2026
Report 3005180920-2026-00598 · MDR key 25677105
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 6r - 11mm
Manufacturer
Medacta International SaModel number
02.12.E0611FRLot number
2401928
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Joint Laxity
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 10 JUN 2026 LOT 2401928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2024. EXPIRATION DATE: 2029-FEB-25. 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
AT 1 YEAR 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY IN FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 11 MM TO 13 MM) TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.