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Evolution Revision CCK System EFDAN608Recalls & reported problems

Microport Orthopedics Inc. · Class 2 · Implant

Data updated Oct 16, 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 M684EFDAN6081), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 2026.

Most reported problems

Device problems

  • Loss of or Failure to Bond1

Patient problems

  • Bone Fracture(s)1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryFeb 17, 2021Loss of or Failure to Bond

    ALLEGEDLY, PATIENT WAS REVISED ON (B)(6) 2018 DUE TO PROSTHETIC JOINT INFECTION WITH NONUNION OF PERIPROSTHETIC FEMUR FRACTURE. FEMORAL AND TIBIAL COMPONENTS, PATELLA REPLACED WITH NON-MPO IMPLANTS BY DIFFERENT SURGEON. (RIGHT KNEE).

    Patient problems: Bone Fracture(s); Unspecified Infection

    MAUDE report 11340193 ↗

Other Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices →

Sources and updates

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