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GMK Revision Total Knee System 02.07.404FDWRecalls & reported problems

Medacta International SA · Femoral wedge distal 4mm, size 4 · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030822476), received between Apr 6, 2018 and Apr 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1
  • 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.

  • MalfunctionApr 6, 2018Loose or Intermittent Connection; Packaging Problem

    THE IMPLANT WAS FOUND LOOSE IN THE BLISTER, OUTSIDE THE INNER PACKAGING, AFTER OPENING THE BLISTER. THE SURGEON USED ANOTHER IMPLANT; NO CRITICAL DELAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7402535 ↗

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

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Sources and updates

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