BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    MDR report key: 6776882 · Received August 9, 2017

    Report

    Report Number
    1020279-2017-00608
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    July 12, 2017
    Report Date
    March 9, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010210128
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE 510KS: K112941, K951987.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. PLEASE SEE THE ATTACHED FILE FOR THE RESULTS OF OUR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REPLACE THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558890 LGN PS HIGH FLEX XLPE SZ 1-2 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH SMITH & NEPHEW, INC. 71420964 11AM15866 03596010210128

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S