BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HEAD

    MDR report key: 2093711 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08244
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    May 25, 2009
    Report Date
    April 12, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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: PT'S HIP BEGAN TO NOTICE INCREASING PAIN AND DISCOMFORT IN HER HIP. BY 2008, THE PAIN AND DISCOMFORT MADE IT DIFFICULT FOR PT TO WALK. HER [PHYSICIAN] DECIDED THAT PT NEEDED TO HAVE HER HIP IMPLANT SURGICALLY REMOVED AND REPLACED AS SOON AS POSSIBLE. OVER THE NEXT TWO MONTHS, PT'S HIP DISLOCATED TWICE. ON (B)(6) 2009, PT UNDERWENT YET ANOTHER SURGICAL PROCEDURE TO REDUCE HER HIP BACK INTO THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY HEAD NONE KWY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention