GMK Hinge Total Knee System 02.09.2604LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030825453), received between Jan 12, 2018 and May 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2013. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION THAT WAS CAUSED FROM FALLING. THE SURGEON REMOVED ALL COMPONENTS AND CONVERTED THE PATIENT TO GMK-HINGE SYSTEM. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT AND INSERT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22042990 ↗
• InjuryNov 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL GMK-HINGE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20693481 ↗
• InjurySep 25, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO FEMORAL COMPONENT DISSOCIATION ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY. TIBIAL INSERT WAS ALSO DISSOCIATED FROM THE TIBIAL TRAY AND THE INSERT SCREW WAS FOUND BROKEN. ALL COMPONENTS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 20300222 ↗
• InjuryMay 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO BROKEN CONDYLE BONE AND FEMORAL COMPONENT LOOSENING AT ABOUT 9 MONTHS FROM THE PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, THE EXTENSION STEM AND THE LINER AS PER STANDARD PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19236562 ↗
• InjuryJun 17, 2022Fracture; Device Dislodged or Dislocated

  REVISION SURGERY 1 MONTH AFTER PRIMARY FOR FEMORAL FRACTURE AND SUCCESSIVE SUBSIDENCE OF THE FEMORAL COMPONENT. INSERT AND FEMUR REVISED SUCCESSFULLY.

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

  MAUDE report 14733582 ↗
• InjuryJan 12, 2018Loose or Intermittent Connection

  REVISION SURGERY WAS NECESSARY 7 MONTHS AFTER PRIMARY DUE TO FEMUR LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 7185381 ↗

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