BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 1884609 · Received October 19, 2010

    Report

    Report Number
    1818910-2010-07835
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    March 7, 2013
    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
    OTHER
    Health Professional
    N

    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 WAS REVISED TO ADDRESS SUSPECTED INFECTION. THE CUP WAS LOOSE AND ROTATED TO A VERTICAL POSITION. TISSUE SAMPLES WERE SENT FOR EVAL WHICH CONFIRMED THE PT WAS NOT INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2363272

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention