BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM EXTENSN, TIB STEM, 15X100MM

    MDR report key: 1931383 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-10145
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K870730
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 FOR OSTEOLYSIS AND LOOSEN, FOUND TIBIAL STEM FRACTURED TOP OF SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM EXTENSN, TIB STEM, 15X100MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 2067150A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention