BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP PROSTHESIS

    MDR report key: 4921642 · Received July 17, 2015

    Report

    Report Number
    1020279-2015-00477
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465868 HIP PROSTHESIS JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R