BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICON-PLUS ACETABULAR COMPONENTS

    MDR report key: 859229 · Received May 24, 2007

    Report

    Report Number
    2086141-2007-00024
    Event Type
    Injury
    Date Received
    May 24, 2007
    Date of Event
    April 24, 2007
    Report Date
    April 24, 2007
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO A BROKEN TITANIUM SHELL HAS BEEN REPORTED IN A CASE IN ANOTHER COUNTRY. ADDITIONAL DETAIL IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICON-PLUS ACETABULAR COMPONENTS LPH LPH PLUS ORTHOPEDICS AG 13206 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention