BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SHIM SZ7 6MM

    MDR report key: 6197788 · Received December 22, 2016

    Report

    Report Number
    1818910-2016-33847
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. FOLLOW UP COMMUNICATION FOR PRODUCT RETURN WAS UNSUCCESSFUL. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. CONTINUE TO MONITOR VIA SEP-419. 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

    ADDITIONAL NARRATIVE: 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 WAS BROKEN WHEN EXPLANTED. THE SHIM WAS FRACTURED. **UPDATE DEC 14, 2016** FOLLOW-UP WITH THE SALES REP INDICATES THE SHIM WAS BROKEN INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849632 ATTUNE SHIM SZ7 6MM KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR