BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL BROACH HANDLE

    MDR report key: 1761171 · Received July 15, 2010

    Report

    Report Number
    1818910-2010-04350
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    SURGEON WAS UNABLE TO REMOVE BROACH FROM PATIENT'S FEMUR WITH BOTH HANDLES, HAD TO GET A REPLACEMENT FROM ANOTHER HOSPITAL. EXTENDED THE SURGERY TIME BY AT LEAST ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL BROACH HANDLE 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA AK0204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA