BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 4233724 · Received November 6, 2014

    Report

    Report Number
    3010536692-2014-01563
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 25, 2012
    Report Date
    October 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01542_01, -01564, -01565. THIS REPORT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT WAS REVISED DUE TO PAIN, DISCOMFORT, DYSFUNCTION AND OTHER SYMPTOMS; ALSO DISEASED JOINT TISSUE AND FLUIDS AS WELL AS FRETTING AND CORROSION AT JUNCTION INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714534 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. 117494958

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention