BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER

    MDR report key: 3803166 · Received May 9, 2014

    Report

    Report Number
    3010536692-2014-00763
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY PT. HAD GRINDING IN HIP. LINER WAS BROKEN IN MULTIPLE PIECES ON THE INFERIOR HALF. HEAD WAS ALSO REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281687 LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention