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GMK Revision Total Knee System 02.07.FCL15105Recalls & reported problems

Medacta International SA · Fluted Extension stem Ø15mm, 105mm · 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 07630030823008), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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

  • Device Slipped1

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.

  • InjuryJan 19, 2018Device Slipped

    THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AFTER PRIMARY. THE FEMORAL EXTENSION STEM SCREW HAD BACKED OUT. THE SURGEON RETRIEVED THE SCREW WITHOUT REPLACING IT. HE ALSO SWAPPED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. DINAMOMETRIC SCREWDRIVER (6NM) WAS USED TO SCREW IT IN DURING THE PRIMARY SURGERY.

    Patient problems: Joint Disorder

    MAUDE report 7204888 ↗

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

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Sources and updates

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