BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE IMPLANT

    MDR report key: 8723640 · Received June 21, 2019

    Report

    Report Number
    1020279-2019-02393
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    January 1, 1901
    Report Date
    October 10, 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 THAT NO CLINICAL INFORMATION HAS BEEN PROVIDED TO PERFORM A THOROUGH MEDICAL INVESTIGATION. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. WITHOUT THE ACTUAL PRODUCT INVOLVED OUR INVESTIGATION CANNOT PROCEED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE FURTHER AS NECESSARY. IF THE DEVICES ARE RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON CONVERTED TO CR DUE TO IT WAS NOT HAPPY WITH THE PATIENT'S LIGAMENT STABILITY. NO ADDITIONAL DETAILS WERE PROVIDED, AND NO MORE INFORMATION IS AVAILABLE AT THIS MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518231 UNKNOWN KNEE IMPLANT PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention