BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII PS HI FLEX ISRT SZ 3-4 9

    MDR report key: 4221660 · Received November 3, 2014

    Report

    Report Number
    8010764-2014-00051
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS GMBH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702368 GII PS HI FLEX ISRT SZ 3-4 9 KNEE IMPLANT JWH SMITH & NEPHEW ORTHOPAEDICS GMBH 11FT07651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention