BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY POLY UNI TIBIA

    MDR report key: 1220337 · Received November 3, 2008

    Report

    Report Number
    1818910-2008-04826
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. ALTHOUGH 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 APPROXIMATELY 17 YEARS OF IMPLANTATION. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF WEAR OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY POLY UNI TIBIA TOTAL KNEE PROSTHESIS HSH DEPUY ORTHOPAEDICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention