BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVATION UNI FEM CEM SZ4

    MDR report key: 2012864 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-03110
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR AND LOOSENING. IT WAS NOTED THAT THERE WAS LITTLE CEMENT ON THE IMPLANTS AND THE IMPLANT CEMENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESERVATION UNI FEM CEM SZ4 87HRY HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2100408

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention