BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS CERAMIC

    MDR report key: 2801153 · Received October 23, 2012

    Report

    Report Number
    9613369-2012-00097
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 25, 1999
    Report Date
    October 17, 2012
    Manufacturer
    SMITH&NEPHEW - SWITZERLAND
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS CERAMIC CERAMIC BALL HEAD 32M LZO SMITH&NEPHEW - SWITZERLAND 9605.15.1268

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R (B)(4) -PLUS BICON TI SHELL - (B)(4)| (B)(4) - SL-PLUS STEM 6 - (B)(4)| (B)(4) -BICON-PLUS INSERT - (B)(4)