BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GNS II RESURF PAT 35MM

    MDR report key: 8339123 · Received February 14, 2019

    Report

    Report Number
    1020279-2019-00572
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 15, 2019
    Report Date
    June 9, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010208316
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HE ASSOCIATED COMPLAINT DEVICES WERE REURNED AND EVALUATED. THE LAB ANALYSIS CONCLUDED, SCRATCHES WERE PRESENT ON THE ARTICULATING SURFACE OF THE PATELLA INSERT. THE INSERT WAS DAMAGED WITH DEFORMATION ON THE BONE CONTACTING SURFACE AND THE SIDES. THE PEGS ARE DEFORMED AND SHEARED. THERE WERE NO OBSERVATIONS OF MATERIAL OR MANUFACTURING DEVIATIONS IN THE COURSE OF THIS INVESTIGATION. THE CLINICAL/MEDICAL TEAM CONCLUDED, IT WAS COMMUNICATED THAT REVISION WAS PERFORMED DUE TO LOOSENING SUPPORTED BY RADIOLOGY. (C-228552). HOWEVER, THE ROOT CAUSE OF THE INTO-OP FINDINGS/PEG DEFORMATION REMAINS UNKNOWN (C-233452). PRIMARY SURGERY DETAILS ARE UNKNOWN. PATIENT IMPACT BEYOND THE REVISION PROCEDURE ITSELF IS NOT ANTICIPATED. IF NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. NO DELAY WAS RECORDED AND NO BACKUP DEVICE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134098 GNS II RESURF PAT 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH SMITH & NEPHEW, INC. 03596010208316

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR