BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CR FEM TRIAL SZ 4 RT

    MDR report key: 6764264 · Received August 3, 2017

    Report

    Report Number
    1818910-2017-22202
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 29, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    UDI-DI
    10603295133766
    PMA / PMN Number
    K140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED AFTER RECEIPT OF REPORTEDLY MALFUNCTIONING PRODUCT FOR ANALYSIS AND EVALUATION THAT THE PRODUCT WAS REPORTED IN ERROR. THEREFORE, THIS REPORT IS CONSIDERED VOID AND WILL BE REJECTED.

    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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TRIAL DAMAGE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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 THE ATTUNE FEMORAL TRIAL WAS FOUND BROKEN AT QMC SPD DEPARTMENT. UPDATE 8/29/2017 UPON RECEIPT OF PRODUCT FOR EVALUATION, IT WAS IDENTIFIED BY THE PRODUCT ANALYST THAT THE PRODUCT WAS NOT BROKEN BUT WAS JUST DEEPLY GOUGED. THIS CHANGES THE CURRENT MDR DECISION TO REPORTABILITY NO. THE MDR TREE AND MEDWATCH WILL BE UPDATED ACCORDINGLY TO ADDRESS THESE FINDINGS. COMPLAINT UPDATED ON:8/29/2017

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIAL WAS FOUND BROKEN AT QMC SPD DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546353 ATTUNE CR FEM TRIAL SZ 4 RT KNEE INSTRUMENT/TRIAL JWH DEPUY ORTHOPAEDICS, INC.1818910 MVMBGY890 10603295133766

    Patients

    Seq Age Sex Outcome Treatment
    1