BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED INSERTS

    MDR report key: 2961678 · Received February 14, 2013

    Report

    Report Number
    1020279-2013-00100
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64927 CONSTRAINED INSERTS GNS II CON INS SZ3-4 13MM JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention