BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 3189344 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02228
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 30, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02115, 02115-1, 02228 AND 02229 ).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. LABORATORY REPORT PROVIDED INDICATES ELEVATED CHROMIUM LEVEL. 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
    291196 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 536600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization