BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 1914185 · Received December 1, 2010

    Report

    Report Number
    1818910-2010-09267
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 16, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT IS SEEKING LEGAL ACTION. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. RECEIVED MEDICAL RECORDS VIA (B)(6) ON (B)(6) 2010 THAT INDICATE THE PT HAS SLIGHT EVALUATION OF ION LEVELS. SURGEON RECOMMENDS MRI SCAN AND PROBABLE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2877592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention