BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXINIUM PRIMARY 40MM MODULAR HEAD

    MDR report key: 4143587 · Received October 6, 2014

    Report

    Report Number
    1020279-2014-00618
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624880 OXINIUM PRIMARY 40MM MODULAR HEAD HIP IMPLANT JDH SMITH & NEPHEW, INC. 14DM05453

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention