BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SIGMA CEMENTED TIBIAL TRAY

    MDR report key: 1327169 · Received February 23, 2009

    Report

    Report Number
    1818910-2009-00882
    Event Type
    Injury
    Date Received
    February 23, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND SEARCH THE COMPLAINT DATABASE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE SUBSIDENCE. BASED ON THE INVESTIGATION FINDINGS, 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, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE TIBIAL TRAY FELL INTO VARUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention