BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 3 CEM

    MDR report key: 3073380 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15809
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    DURING A REVISION TO ADDRESS A FRACTURED POSTERIOR CONDYLE (BONE) WHICH OCCURRED DURING REHAB, LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE WAS ALSO FOUND. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175535 ATTUNE FB TIB BASE SZ 3 CEM TIBIAL KNEE PROSTHESIS JWH DEPUY (IRELAND) 9616671 3476387

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention