BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 1954256 · Received January 5, 2011

    Report

    Report Number
    1818910-2010-10813
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 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
    VA, US
    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

    PATIENT WAS REVISED TO ADDRESS A LOOSE ASR CUP. IT WAS NOTED THAT THERE WAS ZERO INGROWTH ON THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2934260

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention