GMK Revision Total Knee System 02.07.2403RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030821417), received between Jun 4, 2020 and Nov 19, 2020 — classified as 2 injuries.

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.

• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 6 MONTHS AFTER PREVIOUS SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED ANOTHER TEMPORARY SPACER TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD SEVERAL REVISION SURGERIES (6TH FOR THE RIGHT KNEE AND 3RD FOR THE LEFT KNEE). THE REASON FOR THE PREVIOUS REVISION IS UNKNOWN BESIDE THE 4TH REVISION OF THE RIGHT KNEE WHEN THE PATIENT HAD A FALL AND RUPTURED EXTENSOR MECHANISM AND THE LAST, PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10867999 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A FAILED EXTENSOR MECHANISM WHICH WAS CAUSED DUE TO TISSUE DEGENERATION. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THEM TO A GMK HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10118170 ↗