BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG MOD TIB TRAY CEM SZ2.5

    MDR report key: 1033948 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01267
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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

    IT WAS NOTICED THAT THE TIBIAL COMPONENT WAS SIZE 2 (ALL THE LABELING AND ALSO THE COMPONENT ARE MARKED AS 2.5). SURGERY PROLONGED BY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG MOD TIB TRAY CEM SZ2.5 87 JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2565739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA