BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 4749683 · Received May 5, 2015

    Report

    Report Number
    1818910-2015-20082
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Report Date
    April 29, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE COMPLAINT STATES THE ATTUNE FEMORAL IMPACTOR IS CRACKED. THE ATTUNE TIBIAL IMPACTOR IS BROKEN INTO TWO PIECES. THE INVESTIGATION CONFIRMED THAT ONE OF THE IMPACTORS HAD BROKEN AND THE OTHER HAD CRACKED AS REPORTED. EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). THE ATTUNE IMPACTORS HAVE BEEN ANNEALED TO REDUCE RESIDUAL STRESSES. LAB TESTS INDICATE SIGNIFICANT REDUCTION IN RESIDUAL STRESSES OF ANNEALED SAMPLES IN COMPARISON TO UN-ANNEALED SAMPLES HOWEVER A COMPLETE REDUCTION IN STRESSES IS NOT ACHIEVABLE. A FIELD SAFETY NOTICE WAS ISSUED IN NOV 2014 STATING TO REDUCE THE POSSIBILITY OF LEAVING FRAGMENTS IN PATIENTS, THE COMPANY SUGGESTS ADHERING TO THE INSTRUCTIONS FOR USE (IFU), WHICH INCLUDE INSPECTING THE IMPACTOR¿S TO ENSURE THAT NO INSTRUMENTS OR PIECES OF INSTRUMENTS ARE LEFT IN THE SURGICAL SITE PRIOR TO CLOSURE. IT SHOULD BE NOTED THAT CAPA-003835 HAS BEEN INITIATED AND CAN BE REFERENCED FOR FURTHER DETAILS. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE ATTUNE FEMORAL IMPACTOR IS CRACKED. THE ATTUNE TIBIAL IMPACTOR IS BROKEN INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294673 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. AU3357846

    Patients

    Seq Age Sex Outcome Treatment
    1