BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-OVER HOODED LINER, 36MM ID

    MDR report key: 2913003 · Received January 14, 2013

    Report

    Report Number
    2530191-2013-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 11, 2013
    Manufacturer
    STELKAST, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K122773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 36MM HOODED LINER WOULD NOT SEAT INTO THE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20739 CROSS-OVER HOODED LINER, 36MM ID CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM LWJ STELKAST, INC. SC3474 28822-101812

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other