BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2220199 · Received August 15, 2011

    Report

    Report Number
    1818910-2011-15245
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 6, 2011
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT BASED ON THE ELEVATED LEVELS OF COBALT AND CHROMIUM IN PT'S BODY, PT WILL LIKELY BE REQUIRED TO UNDERGO REVISION SURGERY. UPDATE: (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS INDICATE THE PT WAS REVISED TO ADDRESS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTL LTD NA 2434782

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention