BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY BCS II FEMORAL OXIN RT SZ 5

    MDR report key: 7069540 · Received November 29, 2017

    Report

    Report Number
    1020279-2017-01140
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    May 26, 2015
    Report Date
    February 22, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556169919
    PMA / PMN Number
    K111711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS INVOLVED IN THIS EVENT, AS OUTLINED, HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-01141 , 1020279-2017-01142 AND 1020279-2017-01143 . (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 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
    848458 JRNY BCS II FEMORAL OXIN RT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 14LM06963 00885556169919

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 71421032/(B)(4)| 74022214/(B)(4)| 74027232/(B)(4)