BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY TIBIA BASE NP RT SZ 4

    MDR report key: 7069541 · Received November 29, 2017

    Report

    Report Number
    1020279-2017-01143
    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
    03596010554284
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS INVOLVED IN THIS EVENT HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-01140 , 1020279-2017-01141 AND 1020279-2017-01142. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WAS READMITTED (B)(6) 2015 FOR A 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
    848459 JOURNEY TIBIA BASE NP RT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 14JM03460 03596010554284

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 71421032/(B)(4)| 74022115/(B)(4)| 74027232/(B)(4)