GMK Revision Total Knee System 02.07.0212SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030816598), received between Sep 13, 2017 and Jul 9, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER3 YEARS FROM THE PRIMARY DUE TO INFECTION. THE SURGERY WAS COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 25763462 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 10 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23758552 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 9 MONTHS POST MEDACTA PRIMARY, THE SURGEON REVISED ALL THE COMPONENTS IMPLANTING A GMK HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21618336 ↗
• InjuryDec 13, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE INSERT AND FEMUR FOR AN INFECTION (RECIDIVIST INFECTION). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN. FEMUR IMPLANTED ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 9466929 ↗
• InjurySep 12, 2018Microbial Contamination of Device

  REVISION SURGERY PERFORMED DUE TO INFECTION, 2 MONTHS AFTER PRIMARY SURGERY. THIS IS THE SECOND REVISION FOR THIS PATIENT DUE TO INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7868588 ↗
• InjurySep 13, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS (B)(6) FOR (B)(6) . THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6860914 ↗