GMK Total Knee System 02.12.KA03RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716088), received between Oct 15, 2025 and May 8, 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.

• InjuryMay 8, 2026Fracture

  ADDITIONAL SURGERY TO FIX FEMORAL FRACTURE AFTER 2 DAYS FROM THE PRIMARY. INLAY REVISED AS PER STANDARD PROCEDURE, NO OTHER IMPLANTS REVISED. THE SURGEON PERFORMED A WASHOUT AND PLATED THE FRACTURE. A PIN AND ROD WERE PLACED TO FIX FRACTURE CAUSING LAXITY IN THE LIGAMENTS, SO THE SURGEON REVISED THE INSERT FROM A 2R-11MM TO A 2R-13MM AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25123175 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 4 MONTHS AFTER THE PRIMARY THE SURGEON REMOVED THE FEMORAL COMPONENT AND THE INSERT AND PLACED SPACERS WITH ANTIBIOTICS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23289765 ↗