BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR XL ACETABULAR SYSTEM

    MDR report key: 1970528 · Received January 20, 2011

    Report

    Report Number
    1818910-2011-01007
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    August 25, 2010
    Report Date
    December 21, 2010
    Manufacturer
    DEPUY IINTL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    BROADSPIRE CLAIMS PT REVISED FOR UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR XL ACETABULAR SYSTEM 87 KWA KWA DEPUY IINTL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention