BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FB TIBIAL IMPACTOR

    MDR report key: 6744259 · Received July 26, 2017

    Report

    Report Number
    1818910-2017-21810
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 28, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    HWA
    UDI-DI
    10603295130192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT TIBIAL IMPACTOR WAS FOUND BROKEN IN QMC SPD DEPARTMENT. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIBIAL IMPACTOR WAS FOUND BROKEN IN (B)(6) SPD DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525690 ATTUNE FB TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL HWA DEPUY ORTHOPAEDICS, INC.1818910 AU3357846 10603295130192

    Patients

    Seq Age Sex Outcome Treatment
    1