GMK Hinge Total Knee System 02.09.4003LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030825552), received between Jul 12, 2019 and Jul 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Appears to Trigger Rejection

  The patient had primary left knee surgery with competitor products. On (b)(6) 2024, the patient was revised to Medacta GMK-Hinge implants. Presently, on (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout, removed all implants and placed a cemented antibiotic spacer with external fixation. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50005870 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND LINER THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21907227 ↗
• InjuryJul 12, 2019Loose or Intermittent Connection

  WE WERE INFORMED ON JUNE 27TH 2019 OF A REVISION SURGERY, THEN PERFORMED ON (B)(6) 2019, ABOUT 8 MONTHS AFTER PRIMARY, DUE TO KNEE TIBIAL TRAY LOOSENING. ALL HARDWARE REVISED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8784035 ↗

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