GMK Hinge Total Knee System 02.09.2604RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030825460), received between Apr 3, 2019 and Nov 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT 2 MONTHS FROM PRIMARY SURGERY DUE TO DISLOCATION OF THE POST EXTENSION AND THE INLAY FROM THE TIBIAL TRAY. THE SCREW SECURING THE INLAY TO THE TIBIA WAS REPORTED TO BE STILL FIXED TO THE TIBIAL TRAY. NO ISSUE WITH THE OTHER IMPLANTS WAS REPORTED. TORQUE LIMITER WAS USED TO FIX THE SCREW DURING PRIMARY SURGERY. THE JOINT WAS VERY UNSTABLE AND THE SURGEON IMPLANTED A 20MM INSERT. SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT A TRAUMATIC EVENT MAY HAVE OCCURRED BUT IT WAS NOT CONFIRMED.

  Patient problems: Joint Dislocation

  MAUDE report 23669514 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 2 MONTHS DUE TO INSTABILITY CAUSED BY A LOOSE FEMORAL COMPONENT. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, A TIBIAL TRAY AND INSERT WITH ANOTHER COMPANY'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8478388 ↗

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