GMK Total Knee System 02.12.KA12RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716200), received between Nov 18, 2025 and May 22, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryMay 22, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO FEMORAL LOOSENING AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE CEMENTED FEMORAL COMPONANT AND THE INSERT (FROM 11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 25253483 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 6 WEEKS FROM PRIMARY SURGERY (H_MAR_RSK_DJ_24011951), MULTIDIRECTIONAL INSTABILITY WAS DETECTED. NO TRAUMA REPORTED. DURING REVISION SURGERY, THE TIBIAL TRAY COULD BE EXPLANTED BY HAND, WITH NO BONDING WITH CEMENT. HINGE SYSTEM SUCCESSFULLY IMPLANTED. THE PATIENT HAS IMPLANT CAST MEGAPROSTHESIS.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 23579963 ↗