BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM STD

    MDR report key: 3200949 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02428
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 22, 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
    MD, 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 THE LOT RELEASED HAS 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 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 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 RIGHT TOTAL HIP ARTHROPLASTY. LEGAL COUNSEL FOR PATIENT ALLEGES PATIENT EXPERIENCED PAIN, SWELLING, INFLAMMATION, ALTERED GAIT, CLICKING, CATCHING, TENDERNESS, LACK OF MOBILITY, TISSUE/BONE DESTRUCTION, AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMS HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2007 AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303412 SELEX/MAGNUM MOD HD 40MM STD PROSTHSIS, HIP KWA BIOMET ORTHOPEDICS N/A 239630

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R