BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY LG STAT LNG LT 18.0MM

    MDR report key: 2910493 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00327
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 8, 2008
    Report Date
    January 2, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K000207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN, SORENESS, AND DISCOMFORT, INABILITY TO LEAD A NORMAL LIFE, WITH DECREASED RANGE OF HIP MOTION, DIFFICULTY WALKING, STANDING AND SLEEPING, AND DIFFICULTY RISING FROM A CHAIR OR A BED; METALOSIS, GROSSLY LOOSE ACETABULAR AND FEMORAL COMPONENTS AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17348 PRODIGY LG STAT LNG LT 18.0MM FEMORAL STEM LPH DEPUY WARSAW U3EALB000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention