GMK Hinge Total Knee System 02.09.4005RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030825606), received between Aug 5, 2020 and Sep 4, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K130299); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22962315 ↗
• InjuryNov 6, 2024Osseointegration Problem; Osseointegration Problem

  3 YEAR AND 2 MONTHS FROM PRIMARY SURGERY THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIA; THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20620260 ↗
• InjuryDec 7, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY DUE TO THE FEMUR AND TIBIAL TRAY LOOSENING. ALL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15932990 ↗
• InjuryAug 5, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIA. THE CAUSE OF THE LOOSE TIBIA IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, POLY, AND EXTENSION STEM 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10366578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130299. One submission often covers many models, so check the product and lot details in each record.

• Z-2661-2017 · May 19, 2017 · Terminated
  Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
• Z-0275-2016 · Apr 17, 2015 · Terminated
  GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery