GMK Revision Total Knee System 02.07.2402RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030821394), received between Feb 7, 2020 and Feb 10, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryFeb 10, 2021Unstable

  REVISION SURGERY PERFORMED DUE TO LATERAL AND MEDIAL INSTABILITY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY. GMK-REVISION WAS REPLACED WITH A GMK-HINGE.

  Patient problems: Joint Laxity

  MAUDE report 11307782 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, 5 MONTHS AFTER PRIMARY SURGERY, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A MEDACTA FEMUR AND POLY WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10821834 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PREVIOUS REVISION, DUE TO AN ENTEROCOCCUS INFECTION. AFTER MULTIPLE WASHOUTS OF THE WOUND, THE SURGEON DECIDED TO PERFORM A FURTHER REVISION OF THE MEDACTA GMK-REVISION AND INSERTED AN ANTIBIOTIC SPACER BLOCK.

  Patient problems: Unspecified Infection

  MAUDE report 9681074 ↗