BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 3041955 · Received April 9, 2013

    Report

    Report Number
    0001825034-2013-00881
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 12, 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
    US
    Reporter Occupation
    PATIENT

    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. BIOMET PACKAGE INSERT CONTAINS THE FOLLOWING POSSIBLE ADVERSE EFFECTS: 1. MATERIAL SENSITIVITY REACTIONS. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 15. ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00879 / 00881).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THEY UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2013 DUE TO ALLEGED PAIN IN THE GROIN AREA, POPPING & CLICKING, SWELLING, INFLAMED TISSUE, AND ELEVATED METAL ION LEVEL. MODULAR HEAD COMPONENT WAS REMOVED AND REPLACED. 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
    147562 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 303630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R