BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII PS HI FLEX ISRT SZ 7-8 9

    MDR report key: 6726488 · Received July 19, 2017

    Report

    Report Number
    1020279-2017-00542
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 19, 2017
    Report Date
    February 27, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K032295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION:CONCOMITANT DEVICE 510K'S: K951987. PLEASE SEE A SUMMARY OF OUR INVESTIGATION ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE LOOSE POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIAL INSERT WAS FOUND TO BE LOOSENED IN X-RAY IMAGES 40 DAYS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506633 GII PS HI FLEX ISRT SZ 7-8 9 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 13DT29842

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R