BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION(R) VALGUS ROD

    MDR report key: 3833004 · Received May 27, 2014

    Report

    Report Number
    3010536692-2014-00869
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    February 28, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME INCIDENT AS 3010536692-2014-00870. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY THE ROD DOES NOT FIT INTO DISTAL FEMORAL ALIGNMENT GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311338 EVOLUTION(R) VALGUS ROD KNEE INSTRUMENT JWH MICROPORT ORTHOPEDICS INC. 1031685

    Patients

    Seq Age Sex Outcome Treatment
    1