GMK Hinge and Revision TiNbN coated 02.07.4405LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971258013), received between Apr 9, 2026 and Apr 9, 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.

• InjuryApr 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO LOOSE TIBIAL AND FEMORAL COMPONENTS ABOUT 1 YEAR AND 3 MONTHS AFTER THE FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY LEFT KNEE SURGERY USING COMPETITOR PRODUCTS AND WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. THE SURGEON REVISED THE FEMUR, REVISED TIBIAL TRAY, AND REVISED THE SIZE 4 14MM SEMICONSTRAINED LINER TO A 20MM GMK-HINGE INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 24826103 ↗