BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OIN MULTIHOLE II ACE CUP 56MM

    MDR report key: 741931 · Received July 26, 2006

    Report

    Report Number
    1818910-2006-02150
    Event Type
    Injury
    Date Received
    July 26, 2006
    Date of Event
    July 3, 2006
    Report Date
    July 3, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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 PT WAS REVISED DUE TO INFECTION. THE FEMORAL STEM WAS ALSO LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OIN MULTIHOLE II ACE CUP 56MM TOTAL HIP PROSTHESIS KWH DEPUY ORTHOPAEDICS, INC. NA Z4RF11000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention