BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1983159 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01464
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    K954935
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND MASSIVE JOINT EFFUSION. THE STEM AND SLEEVE WERE ALSO LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST, 36+6L NK, 11X16X150 87LPH LPH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2134573

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention