GMK Hinge Total Knee System 02.09.TA510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825743), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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.

• MalfunctionAug 30, 2018Packaging Problem; Packaging Problem

  THE NURSE TOOK THE SIZE 5 AND THE OUTER PACKAGING WAS COMPLETELY INTACT. HE OPENED THE FOIL OF THE INNER PACKAGING AND FOUND THAT THE INNER PACKAGING WAS OPEN. THE SAME ISSUE WAS FOUND FOR THE SIZE 4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832919 ↗

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