BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 643605 · Received October 31, 2005

    Report

    Report Number
    1822565-2005-00206
    Event Type
    Injury
    Date Received
    October 31, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 4, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Removal / Correction Number
    1822565-08/16/2001-02R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN APRIL 22, 1999. CERAMIC FEMORAL HEAD SHATTERED AND WAS REMOVED IN OCTOBER 3, 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL HEAD HIP PROSTHESIS LZO ZIMMER, INC. NA 62441200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R