BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 4801822 · Received May 28, 2015

    Report

    Report Number
    3010536692-2015-01168
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    August 4, 2014
    Report Date
    April 28, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01166, -01167, -01169.

    Description of Event or Problem · 1

    ALLEGED PATIENT REVISED DUE TO MOM COMPLICATIONS: LEFT SIDED HIP PAIN, SERUM COBALT AND CHROMIUM ION LEVELS; ELEVATED METAL PARTICLE DISEASE AND A PSEUDOTUMOR; BROWNISH YELLOW FLUID; BLACK TISSUE; NECROTIC AND FIBRINOUS TISSUE; FOCAL GIANT CELL REACTIONS AND WEAR DEBRIS; HEMATOMA- LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346676 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. 069867827

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention