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GMK Revision Total Knee System 02.07.FCL22065Recalls & reported problems

Medacta International SA · Fluted Extension stem Ø22mm, 65mm · Class 2 · Implant

All models of GMK Revision Total Knee System (71)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030823114), received between Oct 20, 2017 and Oct 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

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

Device problems

  • Packaging Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 20, 2017Packaging Problem; Packaging Problem

    DURING SURGERY WHEN THE STEM WAS OPENED, IT WAS NOTIFIED THAT THE PACKAGING WAS DAMAGED. THE SURGEON USED A SECONDARY IMPLANT FOR THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6965050 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

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