GMK Hinge Total Knee System 02.09.0414HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030825200), received between Jul 7, 2017 and Mar 3, 2026 — classified as 11 injuries.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA GMK-HINGE PRODUCTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 14MM INSERT TO A 12MM GMK-HINGE INSERT WITH EXTENSION AT THE SURGEON`S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24494920 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY UTILIZING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE COMPETITOR COMPONENTS WERE REVISED USING GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP TO ONE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23837300 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO ISSUES WITH RANGE OF MOTION AND THE CAUSE IS UNKNOWN. ABOUT 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DETERMINED A POLY REVISION WAS REQUIRED FOR FLEXION CONTRACTURE OF THE KNEE. THE SURGEON REVISED THE INSERT FROM 14MM TO 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 23461671 ↗
• InjuryAug 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND DISLOCATING THE FEMORAL TIBIAL JOINT. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY ON (B)(6) 2025, THE PATIENT CAME DUE TO SIGNS OF INFECTION WITH THE CAUSE UNKNOWN. THE SURGEON REVISED THE LINER AND POST AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22769927 ↗
• InjuryJul 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS CANDIDA ALBICANS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17296859 ↗
• InjuryOct 31, 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. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH COMPETITOR'S COMPONENTS AND WAS REVISED WITH HINGE SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15698466 ↗
• InjuryMay 16, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOLLOWING INFECTION. THE SURGEON REVISED SUCCESSFULLY THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 14407317 ↗
• InjuryDec 20, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AND A HALF AFTER THE SURGERY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE AND THE CAUSE OF THE STIFFNESS IS UNKNOWN. THE SURGEON REVISED GMK-HINGE TIBIAL INSERT - SIZE 4 - 14 WITH A GMK-HINGE TIBIAL INSERT - SIZE4 - 12 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 13043280 ↗
• InjuryFeb 7, 2019Break

  REVISION SURGERY PERFORMED, LESS THAN ONE YEAR AFTER PRIMARY SURGERY, DUE TO TIBIA DISLOCATION AND SCREW BREAKAGE.

  Patient problems: Joint Dislocation

  MAUDE report 8315266 ↗
• InjuryJun 28, 2018Fracture

  THE PATIENT HAD A PRIMARY ON (B)(6) 2018. ONE MONTH LATER THE PATIENT FELL AND FRACTURED THE FEMUR. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INSERT. IN (B)(6) 2018 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7645867 ↗
• InjuryJul 7, 2017Device Issue; Device Issue

  THE PATIENT HAD PAIN BECAUSE OF A PATELLA TILT AND PATELLA PROBLEMS IN GENERAL. ON THE X-RAY, IT WAS SEEN THAT THE SCREW BACKED OUT FROM THE INLAY. THE REVISION SURGERY IS SCHEDULED FOR THE (B)(6) 2017. THE SURGEON PLANNED TO REMOVE PATELLA AND INSERT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6692963 ↗

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