BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A PRODUCT

    MDR report key: 2172235 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00595
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER ONE STATES,"MATERIAL SENSITIVITY REACTIONS". NUMBER FIFTEEN STATES,"ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT SUBMITTED (B)(4), 2011. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6), 2005. SUBSEQUENTLY, PATIENT EXPERIENCED PAIN AND MUSCLE SPASMS. A HIP FLUID ASPIRATION WAS CONDUCTED AND THE INFECTION CULTURE WAS NEGATIVE. A BLOOD SAMPLE WAS DRAWN AND HIGH METAL ION LEVELS WERE CONFIRMED. PATIENT'S RIGHT HIP WAS REVISED ON (B)(6), 2011. DURING THE PROCEDURE, A PSEUDO-TUMOR WAS ENCOUNTERED AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN M2A PRODUCT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R