GMK Hinge Total Knee System 02.09.4003RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030825569), received between Aug 28, 2019 and Apr 5, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryApr 5, 2022Malposition of Device; Malposition of Device

  REVISION SURGERY AT ABOUT 4 MONTHS AND A HALF AFTER GMK-HINGE SYSTEM IMPLANTATION BECAUSE FOR THE SURGEON THE TIBIAL TRAY WAS BADLY POSITIONED. THE REASON OF HINGE SYSTEM IMPLANTATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14010351 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND COMPETITORS' PRODUCTS WERE IMPLANTED, THE DATE OF THE PRIMARY IS UNKNOWN. ON (B)(6) 2018 THE COMPETITOR DEVICES WERE REVISED AND MEDACTA KNEE SYSTEM IMPLANTED. THE REASON OF THIS REVISION WAS UNKNOWN. 5 MONTHS AFTER MEDACTA SYSTEM IMPLANTATION NEW REVISION SURGERY PERFORMED DUE TO AND INFECTION (THE PATHOGEN WAS UNKNOWN). THE SURGEON IMPLANTED AN ANTIBIOTIC SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CURRENTLY, AFTER 3 MONTHS FROM IMPLANTATION OF THE ANTIBIOTIC SPACER, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8939188 ↗

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