BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN LNR CON +4 NEUT 40IDX62OD

    MDR report key: 1983485 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01267
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K071117
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA AND THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN LNR CON +4 NEUT 40IDX62OD 87KWZ KWZ DEPUY ORTHOPAEDICS, INC. NA E29BK1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention