BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MOD HD SZ 46MM

    MDR report key: 2761029 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01702
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    November 20, 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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - NO KNOWN REVISION DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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." THE PRODUCT AND LOT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WERE NOT PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS NO REVISION PROCEDURE HAS OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION INCLUDING PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01702 AND 1825034-2013-05866 / -05868).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, COUNSEL ALLEGES ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. NO KNOWN REVISION PROCEDURE HAS OCCURRED. 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
    1 M2A MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 894140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R