BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3062293 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-01691
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    October 12, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, GRINDING OF THE HIP JOINT, CLICKING, POPPING, DIFFICULTY WALKING PHYSICAL LIMITATIONS, AN INABILITY TO ENGAGE IN HIS USUAL SOCIAL AND RECREATIONAL ACTIVITIES, WAGE LOSSES, MEDICAL EXPENSES, ELEVATED COBALT AND CHROMIUM LEVELS IN HIS BLOOD, AND PERMANENT DISABILITY AND DISFIGUREMENT, AND MAY REQUIRE EXPLANATIONS THE HIP. ***UPDATE*** 10/12/2011 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(4) 2011. CHANGED UNK ASR HIP TO ASR CUP ADDED FEMORAL HEAD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163370 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2971206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other