BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMPLANT

    MDR report key: 8663520 · Received June 3, 2019

    Report

    Report Number
    1020279-2019-02163
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 13, 2019
    Report Date
    October 9, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND NO CLINICALLY RELEVANT SUPPORTING DOCUMENTATION WAS PROVIDED; THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. HOWEVER, PER COMPLAINT, TIBIAL LOOSENING WAS THE ROOT CAUSE FOR REVISION, ALTHOUGH THE REASON FOR THE LOOSENING REMAINS UNKNOWN. THE PATIENT IMPACT BEYOND THE REPORTED REVISION AND AN EXPECTED BRIEF REHAB PHASE CANNOT BE DETERMINED. SHOULD CLINICAL DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, THE CLINICAL/MEDICAL TASK MAY BE RE-EVALUATED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TIBIA LOOSE. LEGION TIBIA WITH A JLL LOCK WAS REVISED AND A NEW POLY WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457848 KNEE IMPLANT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R