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GUARDIAN® 2500BP16Recalls & reported problems

Microport Orthopedics Inc. · GUARDIAN® BOWED CANAL FILLING STEM 152MM X 16MM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M6842500BP161), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Use of Device Problem1

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.

  • MalfunctionMar 31, 2020Use of Device Problem; Use of Device Problem

    ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY OF THEIR HINGE KNEE SYSTEM. PATIENT HAS A LOT OF CO-MORBIDITIES AND WASN'T MOVING HIS JOINT AND IT STIFFENED UP. COMPONENTS NOT REVISED 25001050, 1557251. 25000007, 1643677.

    Patient problems: Loss of Range of Motion

    MAUDE report 9904343 ↗

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

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices →

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