GMK Hinge Total Knee System 02.09.0623HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825378), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, THE PATIENT UNDERWENT A FIRST REVISION SURGERY DURING WHICH THE STRYKER SCORPIO TS SYSTEM WAS REPLACED WITH GMK-HINGE SYSTEM. AT THE BEGINNING OF 2024, THE PATIENT FELL AT HOME AND FRACTURED HIS FEMORAL BONE AROUND THE KEEL. A PERIPROSTHETIC PLATE AND SCREW OSTEOSYNTHESIS HAVE BEEN IMPLANTED. NO IMPLANTS HAVE BEEN REVISED. ON (B)(6) 2024, THE PATIENT WAS REVISED BECAUSE OF FALLING AND SUBSEQUENT DISLOCATION OF THE JOINT. THE TIBIAL INSERT DETACHED FROM THE TIBIAL TRAY, WHILE THE INSERT SCREW REMAINED IN THE TIBIAL TRAY. THE SURGEON REVISED SUCCESSFULLY THE INSERT WITH A THICKER ONE (FROM 23MM TO 26MM); THE OSTEOSYNTHESIS SCREW WAS ALSO REMOVED BECAUSE THIS WAS PROTRUDING FROM THE BONE AND, PROBABLY DURING KNEE FLEXION, IT COULD GET IN CONTACT WITH THE INSERT ACTING AS A LEVER AND CAUSING THE DISLOCATION OF THE INSERT FROM THE BASEPLATE.

  Patient problems: Joint Dislocation

  MAUDE report 19761208 ↗

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