BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 58MM

    MDR report key: 1884755 · Received October 22, 2010

    Report

    Report Number
    1818910-2010-07872
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    June 16, 2010
    Report Date
    October 19, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K071784
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    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

    LITIGATION PAPERS ALLEGE THE PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN SECTOR W/GRIPTION 58MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA ES2CF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention