BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M

    MDR report key: 15744184 · Received November 7, 2022

    Report

    Report Number
    3010536692-2022-00408
    Event Type
    Injury
    Date Received
    November 7, 2022
    Report Date
    January 4, 2023
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044041
    PMA / PMN Number
    K140043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. STEM/DISLOCATION/SUBLUXATION REVISION NJR NUMBER: 4973583. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. NON-MPO PRODUCTS: PART ID: 65-6400-50-22 F/M ACET SHELL WITH HA-TCP CALCICOAT - 50MM O.D/ LOT. NUMBER: 60358559/ QTY:1. PART ID: 6415-28-02 ALUMINA INSERT 48-54 X 28/ LOT. NUMBER: 61300387/ QTY:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2829370 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04404 X10445480 M684PHA044041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention