BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUNI

    MDR report key: 3113238 · Received May 15, 2013

    Report

    Report Number
    1020279-2013-00261
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215640 JUNI JOURNEY UNI TIBINRT S3-4LM/RL8MM JWH SMITH & NEPHEW, INC. 13AM10958

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 71422345/ 12HM10894| 71422424/ 12EM14874