BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 1984558 · Received January 28, 2011

    Report

    Report Number
    1818910-2011-01092
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PT WAS SCHEDULING REVISION DUE TO PAIN. IT WAS REPORTED TO BROADSPIRE THAT THE REVISION OCCURRED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2628733

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention