BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY PFJ IMPLANT SM LT

    MDR report key: 7023916 · Received November 13, 2017

    Report

    Report Number
    1020279-2017-01006
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 30, 2017
    Report Date
    February 13, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KRR
    PMA / PMN Number
    K051086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Additional Manufacturer Narrative · 1

    CORRECTIONS BASED ON NEW INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS ADDITIONALY REPORTED THAT THE COMPONENT WAS IN AN OPTIMAL POSITION ACCORDING TO THE SURGEON. THE RESON FOR REVISION SURGERY WAS PROGRESSIVE OA LEADING TO MEDIAL COMPARTMENT OA OF THE KNEE AND SURGEON CHOSE TO PERFORM A TOTAL KNEE REPLACEMENT DUE TO THE PATIENT¿S AGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOR UNSPECIFIED REASONS. KNEE CONVERTED TO TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803403 JOURNEY PFJ IMPLANT SM LT PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER KRR SMITH & NEPHEW, INC. 10CM11723

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R