BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMA Z

    MDR report key: 2010949 · Received February 22, 2011

    Report

    Report Number
    2010949
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 22, 2011
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    JDL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MECHANICAL FAILURE OF THE FEMORAL COMPONENT IN A TOTAL HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMA Z HIP, SEMI-CONSTRAINED, STEM JDL WRIGHT MEDICAL * *
    2 PROFEMUR MODULAR NECK HIP, METAL/POLYMER, MODULAR, FEMORAL, NECK LWJ WRIGHT MEDICAL TECHNOLOGY, INC. PHAO-1254 058600594
    3 DYNASTY PROSTHESIS, HIP, ACETABULAR, LINER JDL WRIGHT MEDICAL TECHNOLOGY, INC. DLCO-GF42 127509428
    4 CONSERVE TOTAL PROSTHESIS, HIP, FEMORAL, HEAD JDL WRIGHT MEDICAL TECHNOLOGY, INC. 38AM-4235 068623242

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR