BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL

    MDR report key: 1891424 · Received October 26, 2010

    Report

    Report Number
    1891424
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY PATIENT WITH HIP PAIN AND DEGENERATIVE JOINT DISEASE, UNDERWENT TOTAL HIP ARTHROPLASTY AT ANOTHER FACILITY IN THE SUMMER OF 2009. THE PATIENT WAS SEEN IN THE EARLY FALL OF 2010 WITH INCREASING HIP PAIN. MRI SHOWED PSEUDOTUMOR AND LARGE FLUID COLLECTION. THE FLUID WAS DRAINED AND A HIP ACETABULAR REVISION SURGERY WAS CARRIED OUT SEVERAL MONTHS AFTER. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================METAL ON METAL REACTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL PROSTHESIS, HIP, ACETABULAR COMPONENT, METAL KWA DEPUY ORTHOPAEDICS, INC. 9998-30-760 2786302

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S