GMK Hinge Total Knee System 02.09.0214HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030825064), received between Jun 28, 2017 and Feb 26, 2026 — classified as 11 injuries, 1 malfunction.

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

• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR`S PRODUCTS. ON (B)(6) 2026, THE PATIENT WAS REVISED TO GMK-HINGE. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454886 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED 10 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO INFECTION OF UNKNOWN CAUSE. THE SURGEON CARRIED OUT A WASHOUT AND REVISED THE HINGE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23920104 ↗
• InjuryAug 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20021474 ↗
• InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD COMPETITOR COMPONENTS AND WAS REVISED TO MEDACTA COMPONENTS ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 13078045 ↗
• InjuryMay 28, 2021Break; Break

  REVISION SURGERY PERFORMED 5 YEARS AFTER THE PRIMARY DUE TO TIBIAL INSERT SCREW BREAKAGE. THE SURGEON REMOVED THE BROKEN SCREW AND SWAPPED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11900239 ↗
• MalfunctionJan 8, 2020Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO A LOOSE GMK HINGE POST SCREW 2 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND HE ALSO PERFORMED A POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9563571 ↗
• InjuryJul 4, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 1 YEAR AND 7 MONTHS AFTER PRIMARY DUE TO POST-SCREW UNSCREWING. ALL HARDWARE HAS BEEN REMOVED. THE LOCKING SCREW OF THE INLAY WAS IN THE CORRECT PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762662 ↗
• InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. I&D AND INSERT SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8319911 ↗
• InjuryOct 26, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ONE MONTH AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8008971 ↗
• InjuryApr 19, 2018Unstable

  ABOUT 3 YEARS AFTER PRIMARY THE SURGEON SWAPPED THE PATIENT LINER FOR A KNEE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7442502 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING WITH A HEMATOMA. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 6964492 ↗
• InjuryJun 28, 2017Break; Break

  DURING A REVISION OF GMK HINGE IMPLANTS DUE TO INFECTION, THE SURGEON NOTICED THAT THE SCREW OF THE INLAY WAS BROKEN.

  Patient problems: Unspecified Infection

  MAUDE report 6672558 ↗

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