BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-6

    MDR report key: 3189463 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02237
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 30, 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
    TX, 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 14 OF 16 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02075 / 02077, 02172 / 02174, 02075-1 / 02077-1, 02172-1 / 02174-1 AND 02236 / 02239).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS A LEFT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009 AND A RIGHT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010. FURTHER REVIEW OF MEDICAL RECORDS AND INVOICES REVEALED THAT A TWO STAGE LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2009 TO REMOVE COMPONENTS AND IMPLANT SPACERS DUE TO INFECTION; WITH REIMPLANTATION OF TOTAL HIP OCCURRING ON (B)(6) 2009. REVIEW OF LABORATORY TEST RESULTS PROVIDED INDICATE ELEVATED METAL ION LEVELS. 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
    290983 M2A-MAGNUM 52-60MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 083270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R