BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 3940426 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23650
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED IMPACTOR CONFIRMED THE FRACTURE INITIATION ALONG THE SLOT THAT CONNECTS WITH THE UNIVERSAL HANDLE. A COMPLAINT SEARCH FOUND OTHER REPORTED INCIDENTS OF FRACTURE. PREVIOUS INVESTIGATIONS FOUND EVIDENCE THE IMPACTORS WERE NOT PROPERLY ALIGNED PRIOR TO IMPACTING, CONTRIBUTING TO FRACTURE. EXAMINATION OF THE CURRENT RETURNED PRODUCT SHOWED NO VISIBLE SIGNS OF MISALIGNMENT. THE ROOT CAUSE IS UNKNOWN. TRENDS ARE CURRENTLY BEING MONITORED THROUGH POST MARKET SURVEILLANCE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    TIBIAL IMPACTOR BROKE DIRECTLY BELOW THE UNIVERSAL HANDLE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419210 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J0307

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR