BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 52MM HEAD DIAMETER

    MDR report key: 2760916 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01739
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." DATE OF EVENT & EXPLANT DATE - N/A. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01737 / 01739).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. 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
    1 M2A-MAGNUM MODULAR HEAD 52MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 232230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R