BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2864000 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-29128
    Event Type
    Injury
    Date Received
    December 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (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: PAST AND FUTURE MEDICAL EXPENSES, ATTORNEYS FEES AND COSTS, PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF FUNCTION, USE AND RANGE OF MOTION, DECREASED AND POOR HIP PERFORMANCE AND LONGEVITY, GAIT DISTURBANCE, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, INCREASED LIKELIHOOD OF FUTURE COMPLICATIONS AND SURGERY, INCREASED LIKELIHOOD OF DISABILITY, INCREASED LIKELIHOOD OF ARTHRITIS, FEAR OF FUTURE COMPLICATIONS AND SURGERY, METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND THE BODY AND FEAR OF METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND THE BODY, EXACERBATION OF UNDERLYING HIP JOINT DISORDERS, INTERNAL SCARRING, AND IRRITATIONS AND INJURY TO TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, ONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS ALONG WITH PAST AND FUTURE LOSS OF WAGES, IMPAIRMENT OF EARNING CAPACITY, EMPLOYMENT AND EMPLOYMENT OPPORTUNITIES, DECREASED WORK LIFE EXPECTANCY. **UPDATE: PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 ACETABULAR SHELL KWA DEPUY INTERNATIONAL 2334976

    Patients

    Seq Age Sex Outcome Treatment
    1