BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT OPEN BOX PS FMRL

    MDR report key: 380190 · Received March 5, 2002

    Report

    Report Number
    1825034-2002-00025
    Event Type
    Injury
    Date Received
    March 5, 2002
    Date of Event
    January 18, 2002
    Report Date
    March 4, 2002
    Manufacturer
    *
    Product Code
    JWH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BI-LATERAL TOTAL KNEE ARTHROPLASTY PERFORMED 06/2001. DUE TO REPORTED INFECTION, LEFT KNEE FEMORAL COMPONENT REMOVED 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT OPEN BOX PS FMRL PROSTHESIS, KNEE, COMP JWH * NA 654180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R