GMK Hinge Total Knee System 02.09.0112HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030824982), received between Dec 6, 2017 and Nov 7, 2024 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 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 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD COMPETITOR COMPONENTS BEFORE HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 20630439 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH AND A HALF AFTER THE PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12505598 ↗
• MalfunctionDec 6, 2017Device Issue; Device Issue

  THREE (3) MONTHS AFTER PRIMARY THE PATIENT FELL AND COMPLAINED KNEE PAIN. THE SURGEON DETECTED THAT THE POST SCREW WAS BAKED OUT. THE SURGEON REVISED SUCCESSFULLY THE JOINT IMPLANTING A NEW THICKER LINER.

  Patient problems: Fall; Pain

  MAUDE report 7086829 ↗

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