BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET M2A HIP PROSTHESIS

    MDR report key: 4243501 · Received November 11, 2014

    Report

    Report Number
    3002806535-2014-00255
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DATE OF EVENT - UNKNOWN; EXPIRATION DATE - UNKNOWN; IMPLANT DATE - BETWEEN 2005 AND 2009 (EXACT DATE UNKNOWN); EXPLANT DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A LEGAL REPRESENTATIVE THAT STATED A PATIENT HAD A TOTAL HIP REPLACEMENT BETWEEN 2005 AND 2009. REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE DUE TO "LYMPHOPLASMACYTIC INFILTRATION DUE TO THIRD BODY OR REACTION TO METAL". NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN LEGAL NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727292 BIOMET M2A HIP PROSTHESIS PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R