BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHOLOGY

    MDR report key: 3700247 · Received March 20, 2014

    Report

    Report Number
    3700247
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    September 25, 2013
    Report Date
    March 18, 2014
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    JDH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RIGHT HIP FEMORAL COMPONENT GROSSLY LOOSE; ALSO, METAL-ON-METAL COMPONENT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167703 ANTHOLOGY PROSTHESIS, HIP, FEMORAL STEM JDH SMITH & NEPHEW, INC UNK 11EM14433
    167704 * PROSTHESIS, HIP, FEMORAL HEAD JDH SMITH & NEPHEW, INC UNK 08HW18246

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR