BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR RECONSTRUCTION RING

    MDR report key: 6067054 · Received October 31, 2016

    Report

    Report Number
    1020279-2016-00837
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    November 15, 2003
    Report Date
    April 28, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LITERATURE REVIEW (GOODMAN S, SAASTAMOINEN H, SHASHA N, GROSS A. COMPLICATIONS OF ILIOISCHIAL RECONSTRUCTION RINGS IN REVISION TOTAL HIP ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY. 2004;19(4):436-446). FOR THE CONTOUR RECONSTRUCTION RINGS, THE FOLLOWING INCIDENT WAS FOUND: FRACTURED INFERIOR FLANGE AND LOOSE RING FOLLOWING HIP REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719391 CONTOUR RECONSTRUCTION RING PROSTHESIS, HIP, ACETABULAR MESH JDJ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R