BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP FEM HD COCR CEMENTED 56MM

    MDR report key: 3192843 · Received June 27, 2013

    Report

    Report Number
    3002806535-2013-00113
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    September 7, 2012
    Report Date
    May 31, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 REPRESENTATIVE THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2006. REVISION PROCEDURE PERFORMED ON (B)(6) 2012, ALLEGEDLY DUE TO METALLOSIS AND FRACTURE TO THE HEAD OF THE FEMUR. 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
    291782 RECAP FEM HD COCR CEMENTED 56MM RECAP FEMORAL HEAD KXA BIOMET UK LTD. N/A 944646

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R