BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOBAL AP EXTRACTION HANDLE

    MDR report key: 3040337 · Received January 21, 2008

    Report

    Report Number
    1818910-2007-04780
    Event Type
    Malfunction
    Date Received
    January 21, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE GLOBAL HEAD PART AND LOT NUMBER COMBINATION AND NO OTHER REPORTS FOR THE REPORTED INSTRUMENT PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY (B)(4) CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS DISLOCATION. DURING SURGERY MALFUNCTION OF HANDLE IN REMOVING TAPER CAUSED SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL AP EXTRACTION HANDLE MANUAL ORTHOPAEDIC INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR