BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM

    MDR report key: 6947442 · Received October 13, 2017

    Report

    Report Number
    3010536692-2017-01327
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    September 18, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION, LYSIS SOCKET; LYSIS STEM; MALALIGNMENT STEM. (LEFT) PATIENT ID: 2ND REVISION NJR NUMBER: (B)(6) FIRST REVISION ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION RECEIVED FROM NJR ON (B)(6) 2017: UPDATED PT ID FROM (B)(6). ADDED LINER AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728795 STEM HIP COMPONENT HWT MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention