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GUARDIAN® 25000007Recalls & reported problems

Microport Orthopedics Inc. · GUARDIAN® DISTAL FEMUR LEFT · Class 2 · Implant

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 M684250000071), received between Mar 2, 2021 and Mar 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Unstable1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 2, 2021Unstable; Unstable

    ALLEGEDLY, THERE WAS UNSTABLE CONSTRUCT.

    Patient problems: Insufficient Information

    MAUDE report 11400515 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.