BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY TIBIAL TRAY

    MDR report key: 1213980 · Received October 27, 2008

    Report

    Report Number
    1818910-2008-04829
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING OR POLYETHYLENE WEAR BASED ON THE PROVIDED INFORMATION. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING AND MINIMAL POLY WEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention