BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST, 36+6L NK, 11X16X150

    MDR report key: 1232246 · Received November 13, 2008

    Report

    Report Number
    1818910-2008-04884
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    N/A
    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

    PATIENT REVISED TO ADDRESS LUCENT LINE OF SLEEVE ON XRAY, FOUND SLEEVE AND STEM LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST, 36+6L NK, 11X16X150 87MRA MRA DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS N/A 2244097

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention