BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 3940630 · Received July 17, 2014

    Report

    Report Number
    8010764-2014-00033
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO JOINT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419164 PS GII PS HI FLEX ISRT SZ 3-4 9 JWH SMITH & NEPHEW, INC. 12AT14096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71420182/12CT16277| 71421115/11FM05656