BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 IM ROD 300MM

    MDR report key: 2101575 · Received April 20, 2011

    Report

    Report Number
    1818910-2011-04796
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. IN RESPONSE TO A TREND IDENTIFIED ON A SIMILAR PRODUCT CODE AND FAILURE MODE (B)(4) WAS RELEASED IN (B)(4) 2001, CHANGING THE RAW MATERIAL USED AND THE GEOMETRY OF THE ROD. IN (B)(4) 2002 THE FIELD WAS INSTRUCTED TO RETURN ALL OLD STYLE INSTRUMENTS AND REPLACE WITH NEW. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    INSTRUMENT BROKEN IN THE PT AND HALF CANNOT BE REMOVED, THE PT IS AWARE. CONSULTANT CONFIRMED THAT 3 OR 4 CM OF THE INSTRUMENT BROKE OFF IN THE INTRAMEDULLARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP2 IM ROD 300MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA