BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC HA/PC 6.0MM (TI)

    MDR report key: 3221397 · Received July 11, 2013

    Report

    Report Number
    3002806535-2013-00120
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    October 25, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. 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. THIS REPORT IS 1 OF 4 MEDWATCH REPORTS SUBMITTED FOR THE SAME EVENT. (PLEASE SEE 3002806535-2013-00120 / 0123)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 INCLUDING THE ITEM AND LOT NUMBERS OF THE PRODUCT. ALL INFORMATION REGARDING THE ITEM INCLUDING ITEM NAME, MANUFACTURE DATE AND EXPIRATION DATE, AND 510K # HAVE BEEN PROVIDED IN THE IS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2007. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012, ALLEGEDLY DUE TO INCREASED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319927 TAPERLOC HA/PC 6.0MM (TI) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 903339

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R