BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FB INSRT SZ 6 5MM

    MDR report key: 3892196 · Received June 24, 2014

    Report

    Report Number
    1818910-2014-21830
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED NO ISSUES WHICH MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT.THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE PROVIDED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.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.

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

    Description of Event or Problem · 1

    INFECTED ATTUNE TKR. PATIENT KNEE BECAME INFECTED FOLLOWING ATTUNE TKR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368410 ATTUNE CR FB INSRT SZ 6 5MM KNEE TIBIAL BEARING/INSERT JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 154154

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention