GMK Hinge Total Knee System 02.09.0223HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030825095), received between May 11, 2018 and May 12, 2026 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS. ON (B)(6), 2026, 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, I&D, AND REVISED THE GMK-HINGE INSERT 23MM TO A SAME SIZE INSERT AND REVISED THE GMK-HINGE 23 MM POST EXTENSION TO A SAME SIZE POST EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148952 ↗
• MalfunctionMay 11, 2018Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  AFTER SURGERY THE NURSE FIND THAT A LINER SIZE 2 WAS IMPLANTED IN THE PATIENT FOR ERROR. THE CORRECT LINER SHOULD BE 3. THE SURGEON FINALLY DECIDED TO DON'T REVISE THE PATIENT BECAUSE CONSIDERED THE KNEE STABLE AND THE REVISION POTENTIALLY HARMFUL FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506735 ↗

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