BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE TRAY LID

    MDR report key: 3897182 · Received June 26, 2014

    Report

    Report Number
    1818910-2014-22099
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 12, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINTS SEARCH AND DHR REVIEW DID NOT IDENTIFY ANY ANOMALIES. THIS COMPLAINT IS WITH REGARD TO INFECTED ATTUNE TOTAL KNEE REPLACEMENTS WHICH OCCURRED AT (B)(6). UPON RECEIVING THE COMPLAINT THE DECISION WAS MADE TO MAKE A SITE VISIT TO THE FACILITY IN WHICH THE CLEANING AND RE-STERILIZATION OF THE ATTUNE INTUITION INSTRUMENTS FOR (B)(6) HOSPITAL OCCURS. DEPUY PROVIDED ONSITE TRAINING TO THE SSD STAFF AND INCLUDED AN EXPLANATION OF THE SYMBOLS ON THE INSTRUMENTS, HOW TO ASSEMBLE/DISASSEMBLE THE DEVICES, AND A DEMONSTRATION OF THE CLEANING POSITIONS OF THE INSTRUMENTS WHEN PLACED INTO THE TRAYS AND ITS RATIONALE. THIS WAS DELIVERED TO 5 GROUPS OF SSD STAFF (36 PEOPLE). FROM THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION, AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS ONGOING. 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

    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.

    Description of Event or Problem · 1

    INFECTED ATTUNE TKR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373436 ATTUNE TRAY LID KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC.-1818910 PV0000382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention