BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 3100428 · Received May 8, 2013

    Report

    Report Number
    1818910-2013-05445
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    August 27, 2012
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 ALLEGED THE PATIENT SUFFERED PAIN, SORENESS, DISCOMFORT, DECREASED RANGE OF MOTION OF THE JOINT, DIFFICULTY WALKING, STANDING AND/OR SLEEPING, AND ELEVATED METAL LEVELS (MEASURED AT 19.0 MCG/L COBALT AND 18.0 MCG/L CHROMIUM) DUE TO THE IMPLANTED ASR HIP. DURING THE ASR HIP REVISION PROCEDURE, THE PHYSICIAN REPORTEDLY NOTED AN ACETABULAR COMPONENT WITHOUT BONY INGROWTH, EXTENSIVE FRETTING AT THE TAPER JUNCTION, CHRONIC TISSUE INFLAMMATION WITH A FOREIGN BODY GIANT CELL REACTION, AND EOSINOPHILIC NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201907 ADAPTER SLEEVES 12/14 +2 ADAPTER SLEEVE HIP IMPLANT KWA DEPUY INTERNATIONAL 2762419

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention