Skip to content

GMK Primary Total Knee System 02.07.0410APPSRecalls & reported problems

Medacta International SA · Full-PE PS Tibial Component #4/10 · 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 07630030817595), received between Jul 7, 2020 and Jul 7, 2020 — 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

  • Appropriate Device Problem Term/Code Not Available1

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.

  • InjuryJul 7, 2020Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN REPORTING TIGHTNESS AND A LACK OF RANGE OF MOTION. THE SURGEON REVISED THE FULL-PE PS TIBIAL COMPONENT WITH A REVISION TIBIAL TRAY AND A 14MM POLY 8 MONTHS AFTER PRIMARY. THE SURGEON HAD TO RECUT THE TIBIA AFTER REMOVING THE A FULL-PE PS TIBIAL COMPONENT. THIS CREATED MORE SPACE THAT HAD TO BE FILLED WITH A THICKER POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Disorder

    MAUDE report 10238596 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page