BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2860844 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-16925
    Event Type
    Injury
    Date Received
    December 6, 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
    LA, 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: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON OR ABOUT (B)(6) 2010. PATIENT HAS EXPERIENCED FEAR AND ANXIETY. PATIENT NOW NEEDS MEDICAL MANAGEMENT, INCLUDING MONITORING OF ELEVATIONS OF COBALT AND CHROMIUM LEVELS. ADDITIONALLY, PATIENT IS REPORTEDLY AT RISK FOR SYSTEMIC ILLNESS, PAIN, AND DECREASED MOBILITY. THERE IS NO MENTION OF REVISION SURGERY. UPDATE: (B)(6) 2011 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 3024884

    Patients

    Seq Age Sex Outcome Treatment
    1