BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 3183027 · Received June 21, 2013

    Report

    Report Number
    9613369-2013-00050
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    August 26, 2010
    Report Date
    June 20, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283245 PLUS SL-PLUS MIA STEM 4 NON-CEM JDH SMITH & NEPHEW, INC. B0711091

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 75003761 - BICON-PLUS REXPOL - (B)(4)| 75004173-CERAMIC BALL HEAD 32M - (B)(4)| 75003743 -BICON-PLUS TITANIUM SHELL -(B)(4)