BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BONE CEMENT

    MDR report key: 3252046 · Received July 29, 2013

    Report

    Report Number
    1818910-2013-22344
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROVIDED INFORMATION SUGGESTS THE PATIENT LARGE PHYSICAL STATURE WAS A CONTRIBUTING FACTOR. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. IT WAS THE SURGEON'S OPINION THAT THE PATIENT'S WEIGHT WAS A FACTOR IN THE LOOSENING. POLY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353194 UNKNOWN DEPUY BONE CEMENT BONE CEMENT LOD 9610921 DEPUY CMW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention