BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC PC 9MM

    MDR report key: 3010021 · Received March 18, 2013

    Report

    Report Number
    3002806535-2013-00041
    Event Type
    Injury
    Date Received
    March 18, 2013
    Report Date
    February 19, 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
    NL
    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. DATE OF EVENT - UNKNOWN. EXPLANT DATE - 2012 (EXACT DATE UNKNOWN). INITIAL REPORTER - UNKNOWN. 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 PATIENT'S LEGAL COUNCIL THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2011. REVISION PROCEDURE WAS PERFORMED IN 2012 ALLEGEDLY DUE TO INCREASED METAL ION LEVELS AND UNDEFINED COMPLAINTS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112657 TAPERLOC PC 9MM TAPERLOC FEMORAL STEM LPH BIOMET UK LTD. N/A 1822092

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R