GMK Total Knee System 02.12.KA05LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716118), received between Apr 17, 2025 and May 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING TIBIAL PAIN DUE TO A LOOSE FEMUR AND TIBIA AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA AND TESTING FOR INFECTION CAME BACK NEGATIVE. THE SURGEON REVISED THE GMK-SPHERIKA COMPONENTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) TO GMK-REVISION COMPONENTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) AND ALSO THE PATIENT`S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25297688 ↗
• InjuryApr 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO SIGNS OF INFLAMMATION (SUBQUADRICIPITAL EFFUSION), OF UNKNOWN ORIGIN. PATIENT'S NATURAL PATELLA WAS ALSO RESURFACED. HYPOTHESES REMAIN A POSSIBLE CHONDROLYSIS OF THE PATELLA OR AN ALLERGIC PHENOMENON.

  Patient problems: Inflammation

  MAUDE report 21855347 ↗