GMK-Revision/Hinge Total Knee System 02.09.0220UCHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030879227), received between Sep 25, 2020 and Sep 29, 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.

• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN WAS STAPHYLOCOCCUS AUREUS. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS THE THIRD SURGERY FOR INFECTION ON THIS PATIENT. THE PRIMARY SURGERY WAS ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10600392 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020 IN WHICH COMPETITOR PRODUCTS WERE REMOVED AND THE SURGEON IMPLANTED A GMK-HINGE SPACER WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. ON (B)(6) 2020, THE SURGEON REMOVED THE GMK-HINGE SPACER AND IMPLANTED PERMANENT MEDACTA HARDWARE. ON (B)(6) 2020 (ABOUT 3 MONTHS AFTER PRIMARY), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PRODUCT WAS REVISED. PRESENTLY, ON (B)(6) 2020 (2 DAYS AFTER FIRST REVISION SURGERY) THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10586666 ↗