BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HV CEMENT

    MDR report key: 3804894 · Received May 12, 2014

    Report

    Report Number
    1818910-2014-18536
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY CMW ¿ REG. # 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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

    THIS IS A DUPLICATE REPORT 1818910-2014-18549. THIS REPORT, 1818910-2014-18536 WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2014-18549.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT X-RAYS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS OBTAINED. THE X-RAY IMAGES APPEAR TO BE PHOTOGRAPHS OF THE ORIGINAL X-RAY AND HAVE POOR IMAGE QUALITY. THE IMAGES ALSO HAD REFLECTIVE ATTRIBUTES NEAR THE TRAY¿S EDGES, POSSIBLY FROM CAMERA FLASH, MAKING IT DIFFICULT TO DISCERN REGIONS OF LOOSENING. THE REPORTED COMPLAINT OF TIBIAL LOOSENING CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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 LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284747 UNKNOWN DEPUY HV CEMENT BONE CEMENT LOD DEPUY CMW ¿ REG. # 9610921 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention