BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANCE BONE CEMENT 80G

    MDR report key: 3223581 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21058
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    PP960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE PROVIDED FOR REVIEW. REVIEW OF THE SUPPLIED MEDICAL RECORDS DID NOT FIND ANY EVIDENCE CONFIRMING THE REPORTED DEVICE LOOSENING OR INFECTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY PRODUCT ERROR AS A CONTRIBUTING FACTOR OR 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 INFECTION AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT BOTH INTERFACES. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324215 ENDURANCE BONE CEMENT 80G BONE CEMENT LOD 9610921 DEPUY CMW U2EAC4000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention