BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE MES SIZING/ROT GDE

    MDR report key: 6175256 · Received December 15, 2016

    Report

    Report Number
    1818910-2016-33479
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE OF THE SIZE LOCKING KNOB IS DUE TO THE OVER-MOULDING IS SUSPECTED TO BE ASSOCIATED WITH RESIDUAL STRESSES IN THE POLYMER. THE POLYMER USED HAS NOW BEEN CHANGED FROM RADEL TO AVASPIRE PER (B)(4) AS A RUNNING CHANGE FOR FUTURE BATCHES. THE NEW MATERIAL IS LESS LIKELY TO CRACK DUE TO IT BEING A GLASS FILLED MATERIAL WHICH IS LESS SUSCEPTIBLE TO RESIDUAL STRESSES AND IS RESISTANT TO CRACK PROPAGATION. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED 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). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE INSTRUMENT IS CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830353 ATTUNE MES SIZING/ROT GDE KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. ABA94665

    Patients

    Seq Age Sex Outcome Treatment
    1