GMK PRIMARY TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 5 YEARS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ASEPTIC LOOSENING OF THE TIBIA AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. THE SURGEON REVISED THE GMK-SPHERE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO GMK-HINGE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 GMK-SPHERE 02.07.1203L TIBIAL TRAY FIX CEMENTED S.3L (K090988) LOT 2010232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAR-2021. EXPIRATION DATE: 17-FEB-2026. 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:ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.