BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) NECK

    MDR report key: 6939907 · Received October 11, 2017

    Report

    Report Number
    3010536692-2017-01311
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    November 12, 2015
    Report Date
    September 18, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE INFECTION (RIGHT). SR NJR NUMBER: (B)(4). FIRST REVISION ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION RECEIVED FROM NJR ON (B)(6) 2017: UPDATED PT ID FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720021 PROFEMUR(R) NECK HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention