BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 11X135

    MDR report key: 3203733 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02461
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    July 19, 2012
    Report Date
    June 4, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES."THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00086,00087, 00086-1, 00087-1 AND 02461).THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT LEFT M2A HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2012 . MEDICAL RECORDS PROVIDED INDICATE REVISION WAS ALLEGEDLY DUE TO METALLOSIS, METAL-STAINED TISSUE AND FLUID, PSEUDOTUMOR, ALVAL, AND MALPOSITION OF CUP, DEBRIDEMENT AND ELEVATED METAL IONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304642 BI-METRIC/X POR NC 11X135 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 752740

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R