GMK Hinge Total Knee System 02.09.0417HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030825217), received between Oct 12, 2017 and Jun 9, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS AND WAS REVISED TO MEDACTA IMPLANTS ON (B)(6) 2026. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE SIZE 4 - 17MM INSERT TO A GMK-HINGE SIZE 3 - 12MM AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442527 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THEPATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE SIZE4 - 17MM INSERT TO A SIZE4 - 20MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148955 ↗
• InjuryAug 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 4 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22923098 ↗
• InjuryMar 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. THE SURGEON SWAPPED THE LINER SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16478723 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO STIFFNESS. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND DOWNSIZED THE INSERT (17 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16459845 ↗
• InjuryDec 21, 2022Migration; Migration

  REVISION SURGERY AT ABOUT 4 MONTHS FOR YOKE SCREW (POST SCREW) LOOSENING. A NEW PIVOT WITH PIVOT SCREW WAS IMPLANTED SUCCESSFULLY USING THE TORQUE WRENCH.

  Patient problems: Insufficient Information

  MAUDE report 16022747 ↗
• InjuryJul 23, 2021Material Rupture

  THE PATIENT HAD A PRIMARY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2019, THE PATIENT CAME IN AND HAD THE COMPETITOR COMPONENTS REVISED TO MEDACTA FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 YEAR AND 11 MONTHS AFTER HINGE IMPLANTATION THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED QUAD TENDON. THE CAUSE OF THE RUPTURED QUAD TENDON IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12217045 ↗
• InjuryAug 25, 2020Microbial Contamination of Device

  THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10447978 ↗
• InjuryOct 12, 2017Break; Break

  REVISION DUE TO TIBIAL COMPONENT (ASEPTIC) LOOSENING AND BREAKAGE OF THE INSERT SCREW. THE SURGEON REPLACED THE TIBIAL COMPONENT WITH INLAY AND STEM AND THE 2 WEDGES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THINKS THAT THE SCREW BREAKAGE IS A CONSEQUENCE OF A PATIENT FALL.

  Patient problems: Joint Disorder

  MAUDE report 6944514 ↗

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