GMK Revision Total Knee System 02.07.0110SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030815911), received between Feb 28, 2019 and Jul 5, 2023 — 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.

• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 YEARS AND 8 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17254931 ↗
• InjuryFeb 28, 2019Loose or Intermittent Connection; Unstable

  REVISION SURGERY AFTER 1 YEAR AND 3 MONTHS FROM THE PRIMARY DUE TO INSTABILITY. THE PATIENT WAS STABLE DURING EXTENSION MEDIALLY AND LATERALLY BUT WAS SUBLUXING WITH ANTERIOR FLEXION. THE 10MM LINER HAS BEEN REVISED WITH A 14MM LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8377328 ↗