GMK Hinge and Revision TiNbN coated 02.09.2703RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040721844), received between Mar 24, 2026 and Mar 24, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM COMPETITOR PRODUCTS TO MEDACTA GMK-HINGE. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME PRESENTING INSTABILITY DUE TO FEMORAL AND STEM LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-HINGE FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT, THE GMK-HINGE 14MM INSERT TO A 17MM INSERT FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24674593 ↗