BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 42MM

    MDR report key: 3140733 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01753
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    November 26, 2012
    Report Date
    October 1, 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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, INCLUDING PRODUCT IDENTIFICATION, THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 THESE TYPES OF EVENTS CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. "

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, ALTERED GAIT, CLICKING, CATCHING, TENDERNESS, LIMITED RANGE OF MOTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, PSEUDOTUMOR AND METALLOSIS. A REVIEW OF HISTORY CONFIRMED THE MODULAR HEAD WAS REPLACED DURING THE REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    241601 M2A-MAGNUM MODULAR HEAD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 592160

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R