BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR DIA 40MM

    MDR report key: 3810502 · Received May 14, 2014

    Report

    Report Number
    3002806535-2014-00129
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    December 4, 2013
    Report Date
    May 10, 2016
    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
    UK
    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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; IMPLANT DATE - (B)(6) 2008 (EXACT DATE UNKNOWN); INITIAL REPORTER - UNKNOWN; MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A HIP REPLACEMENT PROCEDURE IN (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2013 DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THE PATIENT UNDERWENT A TOTAL HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO UNKNOWN ALLEGATIONS. 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
    288525 M2A MAGNUM MODULAR HD COCR DIA 40MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1109228

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R