GMK Hinge Total Knee System 02.09.4006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825613), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Fracture; Fracture

  THE PATIENT HAD A PRIMARY KNEE SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2016, THE SURGEON IMPLANTED A GMK FEMORAL COMPONENT AND FULL-PE PS TIBIAL COMPONENT TO ACT AS TEMPORARY SPACERS FOR A 2-STAGE INFECTION PROTOCOL. SUBSEQUENTLY, ON (B)(6) 2017, THE TEMPORARY IMPLANTS WERE EXPLANTED AND HINGE SYSTEM WAS IMPLANTED. PRESENTLY, ABOUT 6 YEARS AND 7 MONTHS AFTER THE PRIMARY MEDACTA SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A BROKEN TIBIAL TRAY. THE SURGEON REVISED ALL IMPLANTS WITH A COMPETITOR'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO TRAUMATIC EVENT HAS BEEN REPORTED. NOTE: THE PATIENT HAS ALSO TIBIAL AND FEMORAL CONE FROM COMPETITOR.

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

  MAUDE report 18324782 ↗

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