GMK Hinge Total Knee System 02.09.4002LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825538), received between Nov 7, 2024 and Nov 7, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryNov 7, 2024Malposition of Device; Malposition of Device

  AT 2 YEARS AND 8 MONTHS FROM MEDACTA PRIMARY SURGERY, REVISION SURGERY DUE TO PATELLA BONE MALTRACKING THAT MIGHT BE CAUSED BY MALPOSITIONING OF THE TIBIAL COMPONENT OR BY AN UNKNOWN PATELLA INJURY. THE SURGEON REMOVED THE TIBIA COMPONENT TO INCREASE THE TIBIAL AUGMENTS (FROM 10 TO 15MM) AND DECREASE THE INSERT SIZE (FROM 12 TO 10 MM) AND PERFORMED A TIBIAL TUBERCLE TRANSFER (TTT) TO IMPROVE THE PATELLA TRACKING. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20630361 ↗

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