BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 46MM

    MDR report key: 2467143 · Received February 24, 2012

    Report

    Report Number
    0001825034-2012-00170
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    April 18, 2011
    Report Date
    January 27, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY BLOOD TEST RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00170 / 00171).

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(4), 2012 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND USER FACILITY REPORT NUMBER REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MEDWATCH IS BEING SENT TO RELAY AN ADDITIONAL REASON FOR THE REVISION PROCEDURE WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER ONE STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER FIFTEEN STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS FOLLOW-UP REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00170-2 / 00171-2). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00171). THE USER FACILITY WAS NOTIFIED OF THE EVENT ON FEBRUARY 23, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO ALLEGED ELEVATED COBALT AND CHROMIUM LEVELS, METAL STAINED TISSUE, AND DETERIORATION OF THE GREATER TROCHANTER. THE MODULAR HEAD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2011 DUE TO ELEVATED SERUM LEVELS AND ALLEGED DETERIORATION OF THE GREATER TROCHANTER. DURING REVISION, ONLY THE HEAD AND TAPER ADAPTOR WERE REMOVED AND REPLACED WITH DUEL ARTICULATING COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MODULAR HEAD 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 705630

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R