BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3570880 · Received January 13, 2014

    Report

    Report Number
    0001825034-2014-00326
    Event Type
    Injury
    Date Received
    January 13, 2014
    Report Date
    May 13, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 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. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00311, 00326, 00397 AND 05180).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00311 & 00326 & 00397).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMED THE MODULAR HEAD, FEMORAL STEM AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE REVISION PROCEDURE PERFORMED ON (B)(6) 2011 WAS DUE TO A LOOSE FEMORAL COMPONENT. THE PATIENT'S OPERATIVE REPORT INDICATES PRESENCE OF SCARRED CAPSULAR TISSUE AND CONFIRMS THE LOOSE FEMORAL COMPONENT. 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 PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2011, DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMED THE MODULAR HEAD, FEMORAL STEM AND TAPER ADAPTER 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
    32946 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 021300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention