BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT BASIC CEMENTED SZ 2

    MDR report key: 1760546 · Received July 15, 2010

    Report

    Report Number
    1818910-2010-04491
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K023453
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT BOTH INTERFACES. COMPETITOR'S CEMENT WAS USED IN PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT BASIC CEMENTED SZ 2 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA BS4CW1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention