BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE DISTAL FEMORAL JIG

    MDR report key: 4695063 · Received April 15, 2015

    Report

    Report Number
    1818910-2015-18695
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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

    ADDITIONAL NARRATIVE: THE COMPLAINT WAS RECEIVED INTO THE (B)(4) COMPLAINT DEPARTMENT (B)(4) 2015 WITH THE COMMENT: FOR ATTUNE® INTUITION DISTAL FEMORAL JIG (PART NUMBERS 254400521 AND 254400520), AS THE METAL PIN BUSHING CAME OUT DURING A BILATERAL ATTUNE TKR CASE ON (B)(4) 2015. NO PRODUCT WAS RETURNED FOR INVESTIGATION. IN SOME INSTANCES THE BUSH HAD BEEN ASSEMBLED INCORRECTLY MAKING IT EASY TO BE PUSHED OUT WITH VERY LITTLE FORCE. THIS WAS IDENTIFIED AS A SUPPLIER FAULT AND CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE TO PREVENT REOCCURRENCE. IN OTHER INSTANCES IT WAS FOUND THAT BUSH HAD BEEN ASSEMBLED CORRECTLY BUT THE SURGEONS HAD NOT FOLLOWED THE SURGICAL TECHNIQUE AND THUS PUT EXCESSIVE LOADING ON THE BUSH CAUSING IT TO BREAK AND FALL OUT. IT IS ADVISED IN THE ATTUNE SURGICAL TECHNIQUE ((B)(4)) THAT ON UNCUT BONE, NON-HEADED PINS BE USED TO MINIMISE THE EFFECT OF THE PIN HEAD PULLING THE JIG OUT OF ALIGNMENT ON TO THE BONE SURFACE. THIS WILL ALSO MINIMISE ABNORMAL/EXCESSIVE LOADING ON THE JIG AND POTENTIAL MISALIGNMENT OF THE DISTAL CUT THROUGH POOR JIG POSITIONING. IN THIS INSTANCE THE CAUSE OF THE PROBLEM CANNOT BE DETERMINED DUE TO THE PRODUCT NOT BEING RETURNED FOR INVESTIGATION. BUSHING RETENTION COMPLAINTS FROM THE DFJ HAVE BEEN ESCALATED THROUGH THE DEPUY SYNTHES QUALITY SYSTEMS TO EVALUATE THE RISKS OF THIS FAILURE MODE ((B)(4)) WITH A FIELD NOTICE ISSUED REINFORCING CORRECT PINNING TECHNIQUE. THE CAUSE OF THE COMPLAINT IS UNDETERMINED. IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE PROVIDED THEN THE COMPLAINT MAY BE REOPENED FOR FURTHER INVESTIGATION. 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

    FOR ATTUNE® INTUITION DISTAL FEMORAL JIG AS THE METAL PIN BUSHING CAME OUT DURING A BILATERAL ATTUNE TKR CASE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251060 ATTUNE DISTAL FEMORAL JIG KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1