BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. MOD TIB TRAY SZ-3N N-8

    MDR report key: 1064721 · Received June 20, 2008

    Report

    Report Number
    1818910-2008-02348
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS , DEPUY-CORK DIVISION
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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

    IN THE PACKAGE OF 2.5 WAS SIZE 2 TIBIAL TRAY. OPERATION TIME EXTENDED 45-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. MOD TIB TRAY SZ-3N N-8 87JWH JWH DEPUY ORTHOPAEDICS , DEPUY-CORK DIVISION NA 2565739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA