BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50M TPR INSRT +3

    MDR report key: 3581337 · Received January 17, 2014

    Report

    Report Number
    0001825034-2014-00454
    Event Type
    Injury
    Date Received
    January 17, 2014
    Report Date
    January 14, 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
    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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 8 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02812-1/02815-1 AND 1825034-2014-00451/00454).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, METALLOSIS AND METAL POISONING. REVIEW OF INVOICE HISTORY INDICATES PATIENT WAS REVISED ON (B)(6) 2007 DUE TO BONE FRACTURE. A CABLE SYSTEM WAS IMPLANTED AND THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED. LEGAL COUNSEL FOR PATIENT ALLEGES THE PATIENT WAS REVISED ON (B)(6) 2011. 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
    44653 M2A-MAGNUM 42-50M TPR INSRT +3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 568220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R