BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE PROSTHESIS

    MDR report key: 6867313 · Received September 14, 2017

    Report

    Report Number
    1020279-2017-00747
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    September 30, 2015
    Report Date
    September 18, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE BE AWARE THAT THE EVENT REPORTED TO YOU THROUGH THIS MDR HAS PREVIOSLY BEEN IDENTIFIED AND REPORTED THROUGH MDR 1020279-2016-00990. FOR THIS REASON THE COMPLAINT FILE ASSOCIATED WITH REPORT 1020279-2017-00747 WILL BE CANCELLED AS A DUPLICATE. WE ASK YOU TO DISREGARD REPORT 1020279-2017-00747.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AFTER A RIGHT KNEE REPLACEMENT AND NEEDED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645044 UNKNOWN KNEE PROSTHESIS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R