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GMK Revision Total Knee System 02.07.0612SCFRecalls & reported problems

Medacta International SA · Tibial insert SC fixed 12mm, size 6 · 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 07630030818912), received between Jul 19, 2021 and Jul 19, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN UNKNOWN). 2 YEARS AND 10 MONTHS AFTER THE FIRST REVISION SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY WITH COMPETITOR COMPONENTS, MEDACTA IMPLANT WAS IMPLANTED IN THE FIRST REVISION.

    Patient problems: Unspecified Infection

    MAUDE report 12187267 ↗

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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