BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2012598 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02818
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 REVISED FOR LOOSE STEM/SLEEVE CAUSED BY POSSIBLE UNDERSIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST, 36+6L NK, 11X16X150 87 MRA MRA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention