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GMK Revision Total Knee System 02.07.FCL13105Recalls & reported problems

Medacta International SA · Fluted Extension stem Ø13mm, 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 07630030822940), received between May 25, 2018 and May 25, 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

  • Pain1

Recent adverse event reports

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

  • InjuryMay 25, 2018Device Slipped

    ON (B)(6) 2018 WE WERE INFORMED ABOUT A LOOSENING OF THE SCREW FROM THE CONNECTION BETWEEN STEM AND FEMUR. THE POST-OP X-RAYS DIDN´T SHOW A LOOSEN SCREW. A REVISION SURGERY IS PLANNED, BUT THE DATE IS NOT DEFINED. PATIENT'S PAIN IS NOT ACUTE, THE LOOSENING OF THE SCREW MAYBE OCCURED EVEN 1 YEAR AGO.

    Patient problems: Pain

    MAUDE report 7544741 ↗

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

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Sources and updates

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