BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED INSERTS

    MDR report key: 2925177 · Received January 22, 2013

    Report

    Report Number
    8010764-2013-00004
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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
    30846 CONSTRAINED INSERTS GNS II CON INS SZ 3-4 15MM JWH SMITH & NEPHEW, INC. 11HT09709

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4)