BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GNS II

    MDR report key: 3932459 · Received July 14, 2014

    Report

    Report Number
    1020279-2014-00414
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 1, 1901
    Report Date
    August 4, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PHYSICIAN, THE ISSUE IS MORE RELATED TO THE ACTUAL SURGERY AND NOT THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS PERFORMED ON THE PATIENT FOR FLEXION AND EXTENSION CONTRACTURE 6 MONTHS AFTER TOTAL KNEE ARTHROPLASTY. PATIENT WAS 6 MONTHS POST-OP ADMITTED TO HOSPITAL AGAIN FOR MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410840 GNS II GNS II C/R FEM SIZE 5 RIGHT JWH SMITH&NEPHEW, INC 13GM14295

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 71420568 -GNS II BICONVEX PAT 26MM - 13GM15520