BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR 44MM

    MDR report key: 3063002 · Received April 17, 2013

    Report

    Report Number
    3002806535-2013-00060
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    October 27, 2012
    Report Date
    March 19, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. INITIAL REPORTER - UNKNOWN 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 TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT ALLEGES ELEVATED METAL ION LEVELS AND OTHER COMPLAINTS. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. 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
    166079 M2A MAGNUM MODULAR HD COCR 44MM M2A MAGNUM MODULAR HEAD KWA BIOMET UK LTD. N/A 2035007

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R