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GMK Primary Total Knee System 02.07.0512APPSRecalls & reported problems

Medacta International SA · Full-PE PS Tibial Component #5/12 · Class 2 · Implant

All models of GMK Primary Total Knee System (99)

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 07630030818271), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (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

  • Unexpected Therapeutic Results1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryFeb 26, 2019Unexpected Therapeutic Results

    ABOUT 3 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR FULL PE PS TIBIAL COMPONENT FAILURE. THE REASON OF FAILURE IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. TIBIAL TRAY AND INSERT IMPLANTED SUCCESSFULLY.

    Patient problems: Failure of Implant

    MAUDE report 8370497 ↗

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

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Sources and updates

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