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Profemur PLS0R415Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR RENAISSANCE STEMREDUCED SZ 15 · 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 M684PLS0R4151), received between Apr 17, 2023 and Apr 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Corroded” (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

  • Corroded1

Patient problems

  • Loss of Range of Motion1
  • Pain1

Recent adverse event reports

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

  • InjuryApr 17, 2023Corroded; Corroded

    ALLEGEDLY, PROFEMUR® TOTAL HIP SYSTEM IMPLANTED IN THE LEFT SIDE HAS FAILED DUE TO CORROSION RELATED METALLOSIS/ADVERSE TISSUE REACTIONS. PATIENT PRESENTED WITH SEVERE PAIN, LACK OF MOBILITY, AND ELEVATED COBALT LEVELS.

    Patient problems: Loss of Range of Motion; Pain

    MAUDE report 16750912 ↗

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

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Sources and updates

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