GMK Hinge Total Knee System 02.09.TA305Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825699), received between Dec 20, 2018 and Dec 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionDec 20, 2018Component Missing; Component Missing

  ABSENCE OF SCREWS IN THE PACKAGING. THE INNER PACKAGE THAT USUALLY CONTAINS THE SCREWS WAS PRESENT BUT NO SCREW WAS FOUND. THE SURGEON USED THE SCREW PRESENT IN THE WEDGE REF 02.07.404FDW, LOT N°169024 (DIFFERENT FROM THE SCREW MISSING) TO COMPLETE THE SURGERY AND CEMENTED THE CONSTRUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184343 ↗

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