BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2942760 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-01745
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    August 29, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K032659
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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. REF. (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 THAT THE PATIENT SUFFERED PAIN, SUFFERING, DISABILITY, AND HAS BEEN EXPOSED TO CHROMIUM AND COBALT AS A RESULT OF THE ASR IMPLANT. THE PATIENT HAS BEEN INJURED PHYSICALLY AND EMOTIONALLY FROM EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT FOUND IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47154 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL 2166201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other