BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2840913 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-25406
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 25, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    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 THE PATIENT EXPERIENCED PAIN, STIFFNESS, CLUNKING, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTS THE PATIENTS MOBILITY AND QUALITY OF LIFE. THE PATIENT WAS ALSO FOUND TO HAVE ELEVATED COBALT AND CHROMIUM LEVELS AND HAS THE NEED FOR MEDICAL MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ACETABULAR CUP ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other