BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 3894936 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21962
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK023012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 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

    EXAMINATION OF THE RETURNED FEMORAL STEM FINDS PLACES WHERE A FILM OF CEMENT MATERIAL HAS ADHERED TO THE SURFACE. THE DISTAL HOLE OF THE SUMMIT STEM IS FILLED WITH HARDENED AND MIXED CEMENT. THE SURFACE FINISH OF THE STEM IS CONSISTENT WITH THE REQUIREMENTS FOR A ZIRCONIA BLAST. NO MARRING OR OTHER SURFACE FINISH ISSUES THAT MAY HAVE INTERFERED WITH ADHESION CAN BE DETECTED BY VISUAL EXAMINATION. IF A PRODUCT-RELATED ISSUE IS AT FAULT FOR THE ADHESION FAILURE, IT WOULD LIKELY BE WITH THE CEMENT. HOWEVER, BECAUSE THE SECOND STEM WAS REPORTED TO HAVE BECOME WELL FIXED IN THE SAME CEMENT MANTLE, IT SEEMS MORE LIKELY THAT THE CEMENT WAS NOT GIVEN ENOUGH TIME TO SET WHEN THE RETURNED STEM WAS ACCIDENTALLY PULLED FREE OF THE CEMENT. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    AFTER SUMMIT BASIC STEM WAS CEMENTED INTO FEMUR, THE SURGEON WAITED UNTIL THE CONTROL PIECE OF CEMENT WAS HARD. HE WENT TO RETRIAL A UNIPOLAR HEAD AND THE STEM CAME OUT OF THE FEMUR, LEAVING ALL THE HARD CEMENT IN THE CANAL, AND NONE ON THE STEM. ANOTHER STEM WAS CEMENTED INTO THE EXISTING CEMENT MANTLE, AND IT HELD FAST. THE CEMENT WAS DEPUY-MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370750 SMARTSET HV BONE CEMENT 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3975884

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention