BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETMV MV ENDURANCE 40 G

    MDR report key: 2954910 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12072
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    PP960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE SUBMITTED X-RAYS COULD NOT CONFIRM THE REPORTED EVENT. 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 INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 WAS REVISED TO ADDRESS RECURRENT KNEE PAIN. INTRAOPERATIVELY, THE FEMORAL COMPONENT AND TIBIAL TRAY WERE FOUND TO BE LOOSE AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. POLY WEAR OF THE TIBIAL COMPONENT WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59354 SMARTSETMV MV ENDURANCE 40 G BONE CEMENT LOD DEPUY CMW 1875456

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention