BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 5314380 · Received December 21, 2015

    Report

    Report Number
    1818910-2015-37969
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 30, 2015
    Report Date
    November 30, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORT STATED THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). BASED ON RECOMMENDATION FROM POLYMER SUPPLIER, THE FB TIBIAL IMPACTOR HAS BEEN ANNEALED TO REDUCE RESIDUAL STRESSES. LAB TESTS INDICATE SIGNIFICANT REDUCTION IN RESIDUAL STRESSES OF ANNEALED SAMPLES IN COMPARISON TO UN-ANNEALED SAMPLES. THE ANNEALED PRODUCT WAS RELEASED IN (B)(6) 2013 A FIELD SAFETY NOTICE WAS ISSUED IN( B)(6) 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 IMPACTORS 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 AN UNJUSTIFIED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FB TIBIAL IMPACTOR BROKE DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840229 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR