BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPIRION FEMORAL COMPONENT

    MDR report key: 2895173 · Received January 3, 2013

    Report

    Report Number
    1020279-2013-00011
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES WERE RETURNED AND EVALUATED. FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE CUSTOM EMPERION TRIAL PILOTS FRACTURED DUE TO DUCTILE OVERLOAD. OVERLOAD FRACTURES CAN OCCUR IF EXCESSIVE BENDING FORCES ARE APPLIED TO THE TRIAL PILOTS, IN EXCESS OF THE MATERIAL STRENGTH. NO MATERIAL DEVIATIONS IN THE TRIAL PILOTS WERE FOUND DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME EXTENDED BEYOND 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839 EMPIRION FEMORAL COMPONENT HIP IMPLANT JDH SMITH & NEPHEW, INC. 021612

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R