BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 2840382 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02455
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    January 27, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02454 / 02456).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT M2A TOTAL HIP ARTHROPLASTY (B)(6) 2010. SUBSEQUENTLY, A REVISION WAS PERFORMED (B)(6) 2012 DUE TO ALLEGED SQUEAKING AND ELEVATED METAL ION LEVELS. THE CUP, HEAD AND ADAPTER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT M2A TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED SQUEAKING AND ELEVATED METAL ION LEVELS. THE CUP, HEAD AND ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S REVISION MEDICAL RECORDS NOTED THE REVISION WAS DUE TO ELEVATED METAL ION LEVELS. MEDICAL RECORDS FURTHER NOTED THE PRESENCE OF FLUID, TISSUE CHANGES CONSISTENT WITH METAL HIP REACTION, METALLOSIS, AND SYNOVITIS. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH A COMPETITOR¿S COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 713710

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R