BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 3222369 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02641
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    May 1, 2015
    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
    ATTORNEY

    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." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.", NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 6 OF 8 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02636 / 02643). 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 THE PATIENT REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT, DYSFUNCTION, LOSS OF RANGE OF MOTION, FLUID, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED. RIGHT SIDE ON (B)(6) 2006 AND LEFT SIDE ON (B)(6) 2007. THERE HAS BEEN NO REPORTED 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
    321808 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 747290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization