BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT CHROME FEMORAL HEAD

    MDR report key: 3133690 · Received May 29, 2013

    Report

    Report Number
    1020279-2013-00287
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    August 15, 2010
    Report Date
    May 23, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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
    234386 COBALT CHROME FEMORAL HEAD HIP IMPLANT JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R