BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM

    MDR report key: 7060325 · Received November 27, 2017

    Report

    Report Number
    1020279-2017-01125
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    April 24, 2015
    Report Date
    February 22, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556179512
    PMA / PMN Number
    K111711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINING COMPONENTS OF THE TOTAL KNEE INVOLVED IN THIS EVENT HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-00985, 1020279-2017-01126 AND 1020279-2017-01127. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFILTRATION WITH DEPO-MEDROL WAS PERFORMED DUE TO HYDROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839287 JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM PRSTHSS,KNEE,PTLLFMRTBAL,SMICNSTRIND,CMNTD,PLYMRMETALPLYMR JWH SMITH & NEPHEW, INC. 11LM02103 00885556179512

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R