BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 3874610 · Received June 16, 2014

    Report

    Report Number
    1020279-2014-00371
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO INSERT DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352265 PS GII PS HI FLEX ISRT SZ 1-2 18 JWH SMITH & NEPHEW, INC. 09KM01552

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 71420180/ 12DM12851