BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY TIBIAL INSERT

    MDR report key: 763284 · Received September 18, 2006

    Report

    Report Number
    1818910-2006-02717
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    August 22, 2006
    Report Date
    August 22, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER 10 YEARS OF IMPLANTATION. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY TIBIAL INSERT TOTAL KNEE REPLACEMENT JHW DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention