GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 9, 2026 · Event occurred Jun 23, 2026
Report 3005180920-2026-00678 · MDR key 25763460
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 4r - 10mm
Manufacturer
Medacta International SaModel number
02.12.E0410FRLot number
2526543
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Medical device site infection
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 26 JUNE 2026 GMK-SPHERE 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM (K202022) LOT 2526543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2025. EXPIRATION DATE: 09-OCT-2030. 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:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.
Description of Event or Problem
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.