BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3181215 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-03189
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    December 2, 2011
    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. 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: PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF FUNCTION, USE AND RANGE OF MOTION, DECREASED AND POOR HIP PERFORMANCE AND LONGEVITY, GAIT DISTURBANCES, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, INCREASED LIKELIHOOD OF FUTURE COMPLICATIONS AND SURGERY, INCREASED LIKELIHOOD 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 IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES, AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. UPDATE: (B)(6) 2011: PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281969 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2475076

    Patients

    Seq Age Sex Outcome Treatment
    1 Other