GMK PRIMARY TOTAL KNEE SYSTEM

Description of Event or Problem

REVISION SURGERY AFTER 4 YEARS AND 7 MONTHS DUE TO A LOOSE PATELLA IMPLANT, AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON OBSERVED THAT THE PATELLA WAS STILL IN PLACE BUT LOOSE AND EASILY REMOVED. THE SURGEON REVISED THE PATELLA RESURFACING S4 TO A MOTO PATELLA E-CROSS D 35 AND REVISED THE 12MM FLEX6L TIBIAL INSERT TO A 10MM FLEX6L TIBIAL INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026 02.07.0036RP RESURFACING PATELLA SIZE 4 (K113571) LOT. 2106040: (B)(4) MANUFACTURED AND RELEASED ON 03 AUGUST 2021. EXPIRATION DATE: 15 JULY 2026. NO ANOMALIES RELATED TO THE ISSUE WERE REPORTED. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.