BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY CUP

    MDR report key: 1082519 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02864
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    THE HANDLE BECAME COLD WELDED DURING SURGERY TO THE CUP EXTENDING THE SURGERY BY 35 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CUP TOTAL HIP REPALCEMENT KWB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA