BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY TIBIA BASE NP LT SZ 6

    MDR report key: 7069962 · Received November 30, 2017

    Report

    Report Number
    1020279-2017-01150
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    August 3, 2015
    Report Date
    March 6, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010554345
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS OF THE TOTAL KNEE PROSTHESIS INVOLVED IN THIS EVENT HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-01149 , 1020279-2017-01151 AND 1020279-2017-01152. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH FLEXION CONTRACTURE AND UNDERWENT A MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850287 JOURNEY TIBIA BASE NP LT SZ 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 14GM06626 03596010554345

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R (B)(4) | (B)(4) | (B)(4)