GMK Hinge Total Knee System 02.09.TA310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030825705), received between Jul 19, 2017 and Oct 20, 2017 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2017Packaging Problem; Packaging Problem

  WHEN THE TIBIAL AUGMENT WAS OPENED, IT WAS NOTICED THAT THE INNER PACKAGING WAS COMPROMISED. THE SURGEON USED A SECONDARY IMPLANT TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 6965054 ↗
• MalfunctionJul 19, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  WHEN THE TIBIAL AUGMENT WAS OPENED, IT WAS NOTICED THAT THE INTERNAL PACKAGING WAS PUNCTURED. THE SURGEON BELIEVED THE STERILITY WAS NOT COMPROMISED SO HE DECIDED TO IMPLANT THE SUBJECT TIBIAL AUGMENT. ALSO, THE PACKAGING OF THE POSTERIOR FEMORAL WEDGE FOUND WAS FOUND TORN. THE SURGEON DID NOT IMPLANT THE SUBJECT POSTERIOR FEMORAL WEDGE AS HE THOUGHT THE STERILITY MAY BE COMPROMISED. THE SURGEON PROCEEDED USING A SECOND IMPLANT (DIFFERENT SIZE) TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724704 ↗

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