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GMK Revision Total Knee System 02.07.2405LRecalls & reported problems

Medacta International SA · Femur revision PS cemented left, size 5 · 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030821448), received between Sep 11, 2019 and Oct 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Pain1
  • Tissue Breakdown1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WENT HOME AFTER THE PRIMARY KNEE SURGERY. WHILE AT HOME, THE KNEE FELT LOOSE AND THE FEMUR TRANSLATED ANTERIORLY, DISLOCATING THE KNEE. WHEN THE DOCTOR ANALYZED THE PATIENT, IT WAS OBSERVED THAT ALL OF THE IMPLANTS ARE STILL IN PLACE AND HAVE NOT DISLOCATED. THE SURGEON DECIDED TO REVISE THE FEMUR TO A REVISION FEMUR AND REVISE THE INSERT WITH A SC INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN SHOWING SIGNS OF INSTABILITY AND DISLOCATION DUE TO A COMPROMISED MCL. THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND TO IMPLANT A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Tissue Breakdown

    MAUDE report 15624374 ↗
  • InjurySep 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    THE PATIENT CAME IN, 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED THE FEMORAL COMPONENT, STEM, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 8987629 ↗

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

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