BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIRCONIA HD +4MM NK 28MM

    MDR report key: 453516 · Received April 15, 2003

    Report

    Report Number
    2935620-2003-00072
    Event Type
    Injury
    Date Received
    April 15, 2003
    Date of Event
    March 14, 2003
    Report Date
    March 28, 2003
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT HAD FIRST REVISION TO THEIR INTERMEDICS CUP IN 1999 DUE TO RECALL. THE HEAD OF THE SULZER MEDICA BROKE INTO 4 PIECES AND HAD TO BE REPLACED AGAIN THIS DAY. AS A RESULT, THE OSTEONICS CUP INSERT ALSO HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIRCONIA HD +4MM NK 28MM HIP PROSTHESIS LZO CENTERPULSE ORTHOPEDICS, INC. NA 1389482

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R