GMK Total Knee System 02.12.KA12LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716194), received between Jan 15, 2026 and Apr 14, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 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.

• InjuryApr 14, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24871652 ↗
• InjuryJan 15, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY, THE PATIENT CAME REPORTING PAIN CAUSED BY ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON OBSERVED FEMORAL NOTCHING WITHOUT FRACTURE. GMK-SPHERIKA COMPONENTS WERE REVISED TO GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 24078374 ↗