BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM

    MDR report key: 7069967 · Received November 30, 2017

    Report

    Report Number
    1020279-2017-01141
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    May 26, 2015
    Report Date
    February 22, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556179062
    PMA / PMN Number
    K111711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS INVOLVED IN THIS EVENT, AS OUTLINED IN D11, HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-01140 , 1020279-2017-01142 AND 1020279-2017-01143 . (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THE PATIENT WAS READMITTED (B)(6) 2015 DUE TO MANIPULATION UNDER ANESTHESIA. THE PATIENT ALSO PRESENTED WITH SWELLING OF THE RIGHT KNEE ON (B)(6) 2016 HOWEVER NO TREATMENT WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO LOSS OF FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850293 JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 12HM00332 00885556179062

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 71421032/14LM02471| 74022115/14LM06963| 74022214/14JM03460