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GMK Revision Total Knee System 02.07.FSC13105Recalls & reported problems

Medacta International SA · Cemented 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 07630030823176), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjuryDec 9, 2019Fracture

    DURING TIBIAL/STEM ASSEMBLY IMPACTION THE TIBIA BONE PARTIALLY FRACTURED DISTALLY. THE SURGEON TREATED IT DISCHARGING THE PATIENT LOAD FOR 45 DAYS.

    Patient problems: Bone Fracture(s)

    MAUDE report 9436907 ↗

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

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Sources and updates

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