GMK Hinge Total Knee System 02.09.0212HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030825057), received between Jul 21, 2017 and Jun 26, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 2 MONTHS FROM PRIMARY DUE TO INFECTION.. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SIZE 2 - 12MM HINGE TIBIAL INSERT TO THE SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25632992 ↗
• InjuryMay 5, 2026Device Appears to Trigger Rejection

  AT3 YEARS 5 MONTHS FROM MEDACTA PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE INSERT SIZE 2 - 12MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25077215 ↗
• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION ABOUT 1 MONTH AFTER FIRST REVISION SURGERY (DUE TO STIFFNESS). THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2024. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 12MM GMK-HINGE INSERT TO A SAME SIZE GMK-HINGE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826104 ↗
• InjuryJun 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 WEEKS FROM 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 LINER AND POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22314129 ↗
• InjuryOct 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PREFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20358132 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  REVISION SURGERY PERFORMED DUE TO HINGE POST SCREW BREAKAGE ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY. ONLY THE POST WAS REVISED.

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

  MAUDE report 19519655 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17831881 ↗
• InjuryNov 8, 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. ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT ORIGINALLY HAD COMPETITOR IMPLANTS AND WAS REVISED TO MEDACTA HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 15750574 ↗
• InjuryMay 27, 2022Unstable

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF MID-FLEXION INSTABILITY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH A HIGHER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14521356 ↗
• InjuryMar 27, 2019Fracture; Fracture

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO HAD THE LINER FIXATION SCREW FREE TO MOVE INTO THE KNEE, 2 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY. ARTHROSCOPIC REMOVAL OF THE SCREW SUCCESSFULLY PERFORMED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8456540 ↗
• InjuryAug 23, 2017Device Dislodged or Dislocated

  THE FIXATION SCREW HAS DISLODGED FROM THE TIBIAL INSERT . AT X-RAY, THE FLOATING SCREW IS VISIBLE IN JOINT BEHIND POSTERIOR CONDYLES.

  Patient problems: Foreign Body In Patient

  MAUDE report 6812785 ↗
• MalfunctionJul 21, 2017Break; Break

  REVISION DUE TO GMK-HINGE POST SCREW BREAKAGE 4 MONTHS AFTER PRIMARY SURGERY. LINER REVISED WITHOUT DIFFICULTIES, THE BROKEN SCREW HEAD WAS ACCESSIBLE IN FRONT OF THE POSTERIOR BOXES. VERIFICATION OF ALL FEMORAL AND TIBIAL PARTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731839 ↗

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