BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® STEM EXT 26MM X 23MM DIA

    MDR report key: 22414495 · Received July 7, 2025

    Report

    Report Number
    3010536692-2025-00288
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    March 26, 2021
    Report Date
    September 4, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, DISTAL STEM BREAKAGE OF THE PROFEMUR R PPW 38006 IMPLANT. BREAKAGE OF THE PART AND CONSEQUENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762563 PROFEMUR® STEM EXT 26MM X 23MM DIA NO MATCH MRA MICROPORT ORTHOPEDICS INC. PPW00142 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention