BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 4122960 · Received September 26, 2014

    Report

    Report Number
    1020279-2014-00592
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 26, 2014
    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 WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601196 PS LGN XLPE PS INSERT SZ 3-4 13MM JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R