BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 3193452 · Received June 27, 2013

    Report

    Report Number
    3002806535-2013-00115
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    December 20, 2012
    Report Date
    March 15, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. NO REVISION SURGERY HAS BEEN REPORTED. 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. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. IMPLANT DATE: (B)(6) 2006 OR (B)(6) 2007. INITIAL REPORTER - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 FROM PATIENT'S LEGAL REPRESENTATIVE INDICATING THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. HE ALSO CORRECTED THE DATE OF THE INITIAL PROCEDURE TO BE (B)(6) 2006, AND NOT 2007.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORT SOURCE - FOREIGN: EVENT OCCURRED IN (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2013-00115, 3002806535-2017-00140.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT UNDERWENT INITIAL HIP PROCEDURE ON (B)(6) 2006, BUT REFERENCE IS ALSO MADE TO A SURGERY ON (B)(6) 2007. THE CLAIM ALLEGES THE PATIENT HAS HIGH METAL ION LEVELS AND A PSEUDO TUMOR. THERE IS NO REFERENCE TO ANY REVISION SURGERY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS AND PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294030 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1113490

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R