BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAMOUNT HIP SIZE 2 RIGHT

    MDR report key: 1030216 · Received April 16, 2008

    Report

    Report Number
    1818910-2008-01467
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K942537
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TO ADDRESS LOOSE STEM, EXCHANGED POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT HIP SIZE 2 RIGHT 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA SF3CC1002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention