BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® MODULAR FEMORAL NECK

    MDR report key: 18787512 · Received February 27, 2024

    Report

    Report Number
    3010536692-2024-00097
    Event Type
    Injury
    Date Received
    February 27, 2024
    Report Date
    February 27, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, LOOSENING - SOCKET/LYSIS - STEM/LYSIS - SOCKET/WEAR OF ACETABULAR COMPONENT SIDE: R. REVISION NJR: 4080719. GENDER: F. EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111008 PROFEMUR® MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01244 101018553 M684PHA012441

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention