BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2488266 · Received March 12, 2012

    Report

    Report Number
    1818910-2012-05977
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    July 27, 2011
    Report Date
    February 13, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED SIGNIFICANT PAIN, SORENESS, AND DISCOMFORT; DIFFICULTY WALKING AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE; ELEVATED METAL IONS LEVEL, MEASURED AT 13.4 MCG/L OF COBALT AND 4.3 MCG/L OF CHROMIUM PRE-REVISION; REVISION SURGERY REVEALING METALLOSIS AND NECROTIC TISSUE; OPPOSITE KNEE PAIN, EMOTIONAL DISTRESS, ANXIETY, AND MENTAL ANGUISH; MEDICAL AND OTHER RELATED EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention