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Profemur PLS0R414Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR RENAISSANCE STEMREDUCED SZ 14 · Class 3 · Implant

All models of PROFEMUR (116)

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 M684PLS0R4141), received between Aug 30, 2021 and Aug 30, 2021 — 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

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

  • InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem

    ALLEGEDLY, PATIENT HAD AN ALLERGIC REACTION DUE TO IMPLANTATION OF HIP SYSTEM.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 12389218 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices →

Sources and updates

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