BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR

    MDR report key: 3003848 · Received March 14, 2013

    Report

    Report Number
    1020279-2013-00160
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 9, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FUNCTIONAL INSTABILITY AND LOOSE IN FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106834 CR GII C/R ART INS SZ 3-4 11MM JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention