GMK Revision Total Knee System 02.07.0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030815607), received between Mar 16, 2018 and Oct 15, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY KNEE SURGERY (B)(6) 2025. THE PATIENT'S FIRST REVISION WAS ON (B)(6) 2025 FOR AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025 THE PATIENT CAME IN AGAIN DUE TO INFECTION WITH AN UNKNOWN CAUSE. THE SURGEON REVISED THE GMK-REVISION SYSTEM TO A GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23291023 ↗
• MalfunctionJun 24, 2020Difficult to Remove

  WHEN TRYING TO ASSEMBLE THE OFFSET ONTO THE TIBIA, THE OFFSET DOES NOT COME OUT OF THE INSTRUMENT (OFFSET ADAPTOR), IT STAYS IN THERE AND DOESN'T CONNECT TO THE TIBIA. THIS HAS HAPPENED A FEW TIMES AND FOLLOWING THE SURGICAL TECHNIQUE CORRECTLY. DUE TO THIS CASE ADDITIONAL ANESTHESIA WAS NECESSARY AND THE SURGERY WAS PROLONGED OF 10 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10189421 ↗
• MalfunctionMar 16, 2018Device Packaging Compromised

  WHEN GETTING THE APPROPRIATE IMPLANTS FOR THE SURGEON THE SALES AGENT NOTICED THAT THE INNER BAG OF THE IMPLANT WAS COMPROMISED. THE AGENT HAD A SECONDARY IMPLANT, SAME LOT, TO COVER THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345472 ↗