BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE ZIRCONIA HEAD 28MM STD

    MDR report key: 397996 · Received June 6, 2002

    Report

    Report Number
    1818910-2002-00345
    Event Type
    Injury
    Date Received
    June 6, 2002
    Report Date
    June 6, 2002
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    JDI
    Removal / Correction Number
    Z-235/238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT MANUFACTURED IN THE UNITED KINGDOM; BUT SOLD IN THE UNITED STATES. PATIENT WAS REVISED DUE TO FRACTURE OF ZIRCONIA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE ZIRCONIA HEAD 28MM STD TOTA HIP PROSTHESIS JDI DEPUY INTERNATIONAL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention