GMK Hinge Total Knee System 02.09.2602RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030825422), received between Sep 8, 2017 and Sep 4, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO ASEPTIC LOOSENING OF PRIMARY HINGE PROTHESIS WITH UNCEMENTED STEMS AT 3 YEARS 10 MONTHS FROM PRIMARY. NO RECUTTING OF THE TIBIA AND FEMUR. REIMPLANTATION OF THE HINGE SYSTEM WITH CEMENTED COMPONENTS AND SENSITIN IMPLANTS.

  Patient problems: Aseptic loosening

  MAUDE report 22961215 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE SURGEON DECIDED TO RESURFACE THE PATIENT'S PATELLA. THE REASON FOR THIS ADDITIONAL PROCEDURE IS UNKNOWN. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. IN 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A SPACER. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED THE SPACER AND IMPLANTED A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE FEMUR, STEM EXTENSION, AUGMENTS, POLY, AND PATELLA, PERFORMED A WASHOUT, AND THEN REIMPLANTED THE PATIENT WITH NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13470615 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, TWO YEARS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8744216 ↗
• InjurySep 8, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF LIMITED RANGE OF MOTION. THE PATIENT HAD 40 DEGREES CONTRACTURE FOLLOWING THE PRIMARY TKA WITH A GMK-HINGE. PREOPERATIVE, THE PATIENT WAS 25 DEGREES CONTRACTURE. THE SURGEON PERFORMED A FEMORAL SHORTENING, WHICH ALLOWED PATIENT TO HAVE FULL RANGE OF MOTION, AND REVISED THE FEMUR, POLY AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 6851057 ↗

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