GMK Hinge Total Knee System 02.09.TA210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030825682), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 injury.

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.

• InjuryJun 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE KNEE REVISION OF A COMPETITOR'S IMPLANTS AND WHILE TRIALING FOR THE AUGMENT, IT WAS OBSERVED THAT THE DIMENSIONAL PROFILE OF THE TRIAL AUGMENT WAS NOT THE SAME AS THE ACTUAL AUGMENT IMPLANT. THE ECCENTRIC CONE COULD BE COUPLED TO THE AUGMENT TRIAL, WHILE THE IMPLANT COULD NOT. THE SURGEON UTILIZED A METAL CUTTING WHEEL TO CUT THE ECCENTRIC CONE, IN ORDER FOR THE AUGMENT TO FIT. THERE WAS A 30-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE THAT AUGMENT SHOULD NOT BE COUPLED WITH THE CONE, THIS IS AN OFF LABEL USE.

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

  MAUDE report 17190147 ↗

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