GMK Hinge Total Knee System 02.09.0420HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030825224), received between Sep 19, 2024 and Aug 12, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Device Appears to Trigger Rejection

  Revision surgery due to infection after about 7 months from first revision surgery. The surgeon performed a washout and revised the 20mm - Size 4 GMK-Hinge insert to a same size insert. The patient ha primary surgery with competitor implants.

  Patient problems: Medical device site infection

  MAUDE report 50222759 ↗
• InjuryNov 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025 THE SURGEONPERFORMED A KNEE REVISION (NON-MEDACTA) FOR INSTABILITY AND IMPLANTED A HINGE PROSTHESIS. ON (B)(6) 2025 THE PATIENT PRESENTED WITH AN INFECTIONAND THE SURGEONPERFORMED LAVAGE AND POLYETHYLENE EXCHANGE ONLY. THE PATIENT IS CURRENTLY RECEIVING ANTIBIOTIC THERAPY WITH TAZOCYCLINE AND DAPTOMYCIN.

  Patient problems: Medical device site infection

  MAUDE report 23615335 ↗
• InjurySep 19, 2024Migration; Migration

  DURING A CHECK-UP, THE INSERT SCREW WAS FOUND UNSCREWED AND MIGRATED. PRIMARY SURGERY PERFORMED 10 YEARS AGO. THE SURGEON IS CONSIDERING REMOVING AND REPLACING THE SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20254284 ↗

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