BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 7 CEM

    MDR report key: 3760980 · Received April 21, 2014

    Report

    Report Number
    1818910-2014-17143
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    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 INVESTIGATION COULD NOT CONFIRM THE REPORTED PATIENT KNEE INFECTION WITH THE INFORMATION AVAILABLE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE PATIENT ONGOING KNEE INFECTION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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.

    Description of Event or Problem · 1

    PATIENT HAD PREVIOUSLY HAD THE TIBIAL INSERT EXCHANGED (B)(4) AND HAS NOW GONE ON TO HAVE ALL COMPONENTS OF THE ATTUNE KNEE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240539 ATTUNE FB TIB BASE SZ 7 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND REG. # 9616671 3601701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention