BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ5 HI OFF

    MDR report key: 1903194 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08184
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A LOOSE STEM, ASSOCIATED WITH PAIN, SHORTENING OF EXTREMITY, DIFFICULTY WALKING. IT WAS ALSO NOTED THAT THE LESSER TROCHANTER WAS BROKEN OFF, AND PROSTHESIS WAS WEDGED IN PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ5 HI OFF 87MRA MRA DEPUY ORTHOPAEDICS, INC. NA EL2DK1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention