BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BONE CEMENT

    MDR report key: 3008688 · Received March 18, 2013

    Report

    Report Number
    1818910-2013-13970
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 LOTS 2972078 AND 2849909. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED FOR THE CEMENT WAS UNAVAILABLE. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LABEL LOT CODE REQUIRED FOR THE STEM WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111438 UNKNOWN DEPUY BONE CEMENT BONE CEMENT LOD 9610921 DEPUY CMW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention