BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE-DUMMY IMPLANT

    MDR report key: 8259227 · Received January 17, 2019

    Report

    Report Number
    1020279-2019-00195
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 18, 2018
    Report Date
    May 7, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO CLINICAL RELEVANT DOCUMENTS WERE PROVIDED TO CONDUCT A THOROUGH MEDICAL ASSESSMENT. NO MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THIS COMPLAINT WILL BE RE-EVALUATED IF MORE INFORMATION BECOMES AVAILABLE. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PATIENT HAD A JOURNEY LL CR KNEE DONE SOME TIME AGO. THE JOURNEY LL KNEE WAS REMOVED AND A GEN LL LDK SZ 3 CR FEMUR AND A SZ 2 9MM ALL POLY TIBIA WAS CEMENTED IN AS A SPACER UNTIL INFECTION IS CLEARED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52011 KNEE-DUMMY IMPLANT PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R