BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER MEDICA

    MDR report key: 449393 · Received March 19, 2003

    Report

    Report Number
    449393
    Event Type
    Injury
    Date Received
    March 19, 2003
    Date of Event
    March 14, 2003
    Report Date
    March 17, 2003
    Manufacturer
    SULZER ORTHOPEDICS
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD FIRST REVISION TO THE 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 SULZER MEDICA ZIRCONIA CERAMIC TOTAL HEAD JDI SULZER ORTHOPEDICS * 1389482

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention