GMK Hinge Total Knee System 02.09.0217HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030825071), received between Sep 26, 2022 and Feb 20, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY LEFT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA GMK-HINGE IMPLANTS. ON (B)(6) 2026, THE PATIENT HAD AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE GMK-HINGE INSERT FROM 17 MM TO A GMK-HINGE INSERT 20 MM PLUS A TINBN GMK-HINGE POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24399530 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT CAME IN REPORTING PAIN AFTER DISLOCATING HER LEG WHILE STILL IN THE HOSPITAL FROM THE PRIMARY SURGERY. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22328101 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION AT ABOUT 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE INSERT AND PERFORMED A WASHOUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17404017 ↗
• InjuryNov 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 15825357 ↗
• InjurySep 26, 2022Fracture; Fracture

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AT ABOUT 6 MONTHS AFTER THE PRIMARY AND THE X-RAYS INDICATED THAT THE FIXATION SCREW OF THE GMK-HINGE TIBIAL INSERT WAS BROKEN. DURING THE PRIMARY SURGERY, THE INSERT SCREW WAS TIGHTENED SUCCESSFULLY USING A 3NM TORQUE. REVISION SURGERY NOT YET PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 15483656 ↗

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