BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 1170012 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-03769
    Event Type
    Injury
    Date Received
    September 18, 2008
    Report Date
    August 20, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. 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 PATIENT WAS REVISED BECAUSE OF FRACTURE OF THE NECK OF THE FEMUR A FEW DAYS AFTER PRIMARY. A BAD QUALITY OF SPONGIOSA BECAME EVIDENT AFTER OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 46 87KXA KXA DEPUY INTERNATIONAL, LTD. NA 1182023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention