BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY TIBIAL INSERT

    MDR report key: 2992846 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13386
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE PROVIDED X-RAYS AND PRODUCT PHOTOGRAPH CONFIRMED THE POLY WEAR AND INSERT FRACTURE. OSTEOLYSIS COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. 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 AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. 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

    DURING A REVISION TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE, WITH COMPETITOR CEMENT HAVING BEEN USED AT THE TIME OF ORIGINAL IMPLANTATION, OSTEOLYSIS AND A BADLY WORN AND FRACTURED TIBIAL INSERT WERE ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97667 UNKNOWN DEPUY TIBIAL INSERT TIBIAL KNEE INSERT JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention