BEUDAMED
    FDA Recall Terminated

    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

    Recall: Z-1820-2013 · Initiated July 11, 2013

    Recall

    Recall Number
    Z-1820-2013
    Event Number
    65591
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 11, 2013
    Posted
    July 31, 2013
    Terminated
    July 10, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

    Reason

    The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

    Action

    On 7/11/13, URGENT MEDICAL DEVICE RECALL NOTIFICATIONS were sent to consignees: Depuy Distributors, hospitals, and surgeons. End-user Hospital Customers will submit reconciliation forms to DePuy. Possible clinical implications of device failure are stated in these notifications, including poor mechanics and loss of function, pain, component dislocation, adverse tissue reaction, bone damage, potential need for revision surgery and the risks associated with this type of surgery. A patient letter will be included with the surgeon letter to assist in surgeon's notification and discussion with patients. The devices will be returned to DePuy Warsaw through the normal DePuy Returns process, to attention of Returns and marking H13-13 on the outside of the box. If a patient presents with a fractured LPS" Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines LPS" Lower Extremity Dovetail Intercalary component is the best treatment option, DePuy plans to make the LPS" Lower Extremity Dovetail Intercalary component available through authorized approvals. Directions on how to purchase the component are provided in the Recall Communications. Any questions or concerns about the recall, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8am-5pm EDT)

    Distribution

    Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.

    Quantity

    58 U.S. / 39 OUS