GMK SPHERE TOTAL KNEE SYSTEM
Received Jul 16, 2026 · Event occurred Jul 9, 2026
Report 3005180920-2026-00745 · MDR key 25838714
Device
Generic name
Gmk-sphere Tibial Insert E-cross - Flex 6r - 11mm
Manufacturer
Medacta International SaModel number
02.12.E0611FRLot number
2346990
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Joint Laxity
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 13 JULY 2026 GMK-SPHERIKA 02.12.E0611FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 6R - 11MM (K202022) LOT 2346990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2024. EXPIRATION DATE: 19-DEC-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: 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
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY MID-FLEXION DUE TO A PCL TEAR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT FROM 11MM TO 17MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.