GMK Hinge Total Knee System 02.09.0520HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030825293), received between Dec 28, 2022 and Jun 9, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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.

• InjuryJun 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER 2 YEARS AND 6 MONTHS FROM THE PRIMARY DUE TO INFECTION, AND THE PATHOGEN RETURNED AS STAPHYLOCOCCUS AUREUS. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE GMK-HINGE SIZE 5 - 20MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442539 ↗
• InjuryApr 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19080200 ↗
• InjuryDec 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE KNEE INCISION OPENING UP DURING PHYSICAL THERAPY. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND POST EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16061012 ↗

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