BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII OVAL RESURFACING PAT 32MM

    MDR report key: 7057907 · Received November 24, 2017

    Report

    Report Number
    1020279-2017-01113
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    June 12, 2013
    Report Date
    February 21, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010485069
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS INVOLVED IN THIS EVENT HAVE BEEN COMMUNICATED THROUGH MDRS: 1020279-2017-01114 , 1020279-2017-01013 AND 1020279-2017-01112 . [(B)(4)].

    Description of Event or Problem · 1

    FURTHER ON IT WAS CLARIFIED THAT PATIENT UNDERWENT TOTAL KNEE EXCHANGE WITH REVISION OF ALL COMPONENTS, RATHER THAN JUST THE POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY (FLUSH AND POLY EXCHANGE) DUE TO PATIENT'S KNEE INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836539 GII OVAL RESURFACING PAT 32MM PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY JWH SMITH & NEPHEW, INC. 13BM04126 03596010485069

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R