BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 62ODX56ID

    MDR report key: 3395972 · Received October 9, 2013

    Report

    Report Number
    0001825034-2013-04528
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    September 13, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT WAS REPORTED PRIOR TO THIS REPORT FOR THE SAME EVENT ON 3 MDRS (REFERENCE 1825034-2013-002732 / 02734).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, FLUID, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS A SECOND REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012, WAS DUE TO ACETABULAR CUP LOOSENING AND PRESENCE OF A PSEUDOTUMOR. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD, TAPER ADAPTER, AND ACETABULAR CUP WERE REMOVED AND REPLACED. 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
    512262 M2A-MAGNUM PF CUP 62ODX56ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 505080

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R