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GMK Primary Total Knee System 02.07.2015RRecalls & reported problems

Medacta International SA · Femur Narrow cemented STD Right, size 5 · 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 07630030820380), received between Mar 7, 2018 and Mar 7, 2018 — 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.

  • InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem

    TWO YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INFECTION (B)(6) ((B)(6)). THE SURGEON REVISED SUCCESSFULLY THE PATIENT SWAPPING FEMUR, TIBIA AND LINER.

    Patient problems: Unspecified Infection

    MAUDE report 7319831 ↗

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

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Sources and updates

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