BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 2.5 10MM

    MDR report key: 1012974 · Received March 12, 2008

    Report

    Report Number
    1818910-2008-00519
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 12, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PMA087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 TO ADDRESS SPINEOUT OF THE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF INS SZ 2.5 10MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA B1RBT4000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention