BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR CUP

    MDR report key: 2221164 · Received August 24, 2011

    Report

    Report Number
    9613369-2011-00036
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    November 17, 2010
    Report Date
    August 23, 2011
    Manufacturer
    SMITH AND NEPHEW, SWITZERLAND
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISON SURGERY WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CUP FEMORAL COMPONENT JDI SMITH AND NEPHEW, SWITZERLAND A0500086

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R