BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANCE BONE CEMENT 40G

    MDR report key: 4113533 · Received September 24, 2014

    Report

    Report Number
    1818910-2014-28758
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    February 12, 2014
    Report Date
    September 9, 2014
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PP960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED THE TIBIAL COMPONENT WAS LOOSE AND SUBSIDED. THE ROOT CAUSE OF THE DEVICE LOOSENING AND MIGRATION IS UNKNOWN. WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES POLY WEAR AND TIBIAL LOOSENING AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED. DER FROM SALES FIELD WAS ALSO RECEIVED STATING TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596078 ENDURANCE BONE CEMENT 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention