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GMK Revision Total Knee System 02.07.0323SCFRecalls & reported problems

Medacta International SA · Tibial insert SC fixed 23mm, size 3 · 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 07630030817557), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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

  • Unstable1

Patient problems

  • Joint Disorder1

Recent adverse event reports

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

  • InjuryApr 4, 2018Unstable

    REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY, THE CAUSE OF THE INSTABILITY IS DUE TO A RETINACULAR TEAR (ABOUT 1 MONTH FROM PRIMARY). THE SURGEON UP SIZED THE POLY OF 3MM. THE PATIENT WAS ALREADY UNDERWENT TO DIFFERENT SURGERIES DUE TO MULTIPLE INFECTIONS BEFORE THIS REVISION.

    Patient problems: Joint Disorder

    MAUDE report 7395350 ↗

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

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Sources and updates

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