GMK Hinge Total Knee System 02.09.2603RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030825446), received between Sep 14, 2018 and Jul 25, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND FUSED THE PATIENT'S KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15093711 ↗
• InjuryJan 15, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  TKA ON THE RIGHT KNEE, PRIMARY SURGERY ON (B)(6) 2017 USING MEDACTA GMK HINGE PRODUCTS, THIS SURGERY WAS ALREADY INDICATED FOR A REVISION AS A LOOSENING OF THE KNEE PROSTHESIS. ON (B)(6) DURING A SURGERY TO REPAIR THE EXTENSION APPARATUS ON THE PATIENT'S RIGHT KNEE (THE INDICATION FOR THIS SURGERY WAS NOT FOR A KNEE REVISION) THE SURGEON NOTICED A METALLOSIS AND LOOSENING ON THE FEMORAL COMPONENT. THE POST SCREW WAS A BIT DISENGAGED WITH THE IMPLANT BUT STILL HOLDING. THE SURGEON HAD TO REPLACED WITH GMK REVISION PRODUCT.

  Patient problems: Toxicity

  MAUDE report 11176319 ↗
• MalfunctionSep 14, 2018Manufacturing, Packaging or Shipping Problem

  DURING A SURGERY, THE BOX OF A GMK HINGE FEMUR SIZE 3 RIGHT (CODE 02.09.2603R - LOT 173034) WAS OPENED AND A GMK HINGE FEMUR SIZE 5 LEFT (CODE 02.09.2605L - LOT 173033) WAS FOUND INSIDE. THE SURGEON COMPLETED THE SURGERY IMPLANTING A GMK-HINGE FEMORAL COMPONENT SIZE 4R GIVEN THAT A GMK-HINGE FEMORAL COMPONENT SIZE 3R BACK-UP WAS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876585 ↗

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