BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CONV FB PS TB TRL SZ6

    MDR report key: 4974679 · Received August 5, 2015

    Report

    Report Number
    1818910-2015-27475
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF A MISSING BALSEAL ON THE LARGER POST OF THE TRIAL. HHE/QRB (QUALITY REVIEW BOARD) (B)(4) RECOMMENDED A DEVICE CORRECTION WHICH WAS INITIATED ON JUNE 12, 2015. CAPA-(B)(4) DETERMINED THE LIKELY ROOT CAUSE TO BE RELATED TO MISUSE, AND REQUIRES MANDATORY SALES TRAINING ON PROPER USE AND APPLICATION OF THE DEVICE BY DEPUY SALES CONSULTANTS. CAPA-(B)(4) WILL ALSO MONITOR THE MANDATORY FIELD TRAINING. THE NEED FOR FURTHER CORRECTIVE ACTION WAS NOT INDICATED. CONTINUE TO MONITOR DISASSOCIATION EVENTS PER POST MARKET SURVEILLANCE (B)(4). 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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

    DEPUY STILL 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.

    Description of Event or Problem · 1

    METAL SPRING BECAME DISASSOCIATED FROM INSERT TRIAL DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515087 ATTUNE CONV FB PS TB TRL SZ6 KNEE INSTRUMENT/TRIAL JWH DEPUY ORTHOPAEDICS, INC. BFA0M9X

    Patients

    Seq Age Sex Outcome Treatment
    1