BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV 20G

    MDR report key: 3113542 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17096
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY CMW/REG. #9610921
    Product Code
    LOD
    PMA / PMN Number
    PK023012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE FEMORAL PART AND LOT NUMBER COMBINATION; ONE ADDITIONAL REPORT FOR THE CEMENT PART AND LOT NUMBER COMBINATION. (B)(4) REVIEWED THE DEVICE HISTORY RECORDS FOR THE CEMENT LOT AND FOUND THE FINAL MICRO AND STERILITY TESTS PASSED. THE RETAINED SAMPLES COULD BE NOT BE TESTED ON THIS PRODUCT AS IT HAS BEEN IDENTIFIED AS BEING APPROXIMATELY 5 YEARS OLD AND THE RETAINED SAMPLES HAVE EXPIRED RETENTION IN ACCORDANCE WITH THE DEPUY RETAINED SAMPLE PROCEDURE SCP-QC01. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    PATIENT WAS REVISED TO ADDRESS PAIN. LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE WAS FOUND. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215543 SMARTSET HV 20G BONE CEMENT LOD DEPUY CMW/REG. #9610921 2280256

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention