BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC FEMORAL COMPONENTS

    MDR report key: 6407475 · Received March 15, 2017

    Report

    Report Number
    3002806535-2017-00131
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 21, 2011
    Report Date
    March 15, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PNOT CLEARED
    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

    CMP-(B)(4). (B)(4). REPORT SOURCE - FOREIGN: EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET US MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K030055. 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: 3002806535-2017-00129, 3002806535-2017-00130, 3002806535-2017-00131.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, LOOSENING, PSEUDOTUMOR, AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, THE PSEUDOTUMOR WAS REMOVED AND PATHOLOGIC ANATOMIC RESEARCH DETERMINED DENUDATION OF THE SYNOVIAL SURFACE WITH FIBRINE AND NECROSIS AS WELL AS INDICATION FOR METALOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190544 BI-METRIC FEMORAL COMPONENTS PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 935591

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R PN 139254 LN 1110475 M2A MAGNUM SYSTEM| PN 157446 LN 1115732 M2A MAGNUM SYSTEM| PN 157852 LN 1093437 M2A MAGNUM SYSTEM