BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SPACER BLOCK

    MDR report key: 7024437 · Received November 13, 2017

    Report

    Report Number
    1818910-2017-28819
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 16, 2017
    Report Date
    December 14, 2017
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    HWT
    UDI-DI
    10603295395379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE(S) CONFIRMS THE REPORTED EVENT. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(B)(4).

    Additional Manufacturer Narrative · 1

    .

    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.

    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

    IT WAS REPORTED THAT THE CONNECTOR CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803923 ATTUNE SPACER BLOCK KNEE INSTRUMENT/TRIAL HWT DEPUY IRELAND 961610  BFA0P57 10603295395379

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR