BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUNI

    MDR report key: 2981229 · Received February 27, 2013

    Report

    Report Number
    1020279-2013-00131
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    July 21, 2009
    Report Date
    February 25, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84387 JUNI JOURNEY UNI TIB BASE RM/LL SZ 5 JWH SMITH & NEPHEW, INC. 07CM22683

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 71420572/ 07AM13541| 71422218/ UNK| 71422265/ 07BM11631