BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 2802944 · Received October 24, 2012

    Report

    Report Number
    1818910-2012-23486
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES THAT HAVE BEEN RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KWB DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1