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GUARDIAN® 25001060Recalls & reported problems

Microport Orthopedics Inc. · GUARDIAN® COCR FEMORAL MID SECTION 60MM · 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 M684250010601), received between Dec 11, 2019 and Dec 11, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Loss of Range of Motion1

Recent adverse event reports

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

  • InjuryDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT HAD A FLEXION CONTRACTURE AND THEY SWAPPED A LONGER MIDSECTION OUT FOR A SHORTER BODY.

    Patient problems: Loss of Range of Motion

    MAUDE report 9453494 ↗

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

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Sources and updates

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