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GUARDIAN® 25001040Recalls & reported problems

Microport Orthopedics Inc. · GUARDIAN® COCR FEMORAL MID SECTION 40MM · Class 2 · Implant

All models of GUARDIAN (22)

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 M684250010401), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

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.

  • InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem

    ALLEGEDLY, IN THE REVISION ON (B)(6) 2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.

    Patient problems: Pain

    MAUDE report 14104374 ↗

Other Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer devices

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Sources and updates

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