BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SMARTSET CEMENT

    MDR report key: 1790092 · Received August 5, 2010

    Report

    Report Number
    1818910-2010-05251
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE TIBIA TRAY AND FEMORAL PART AND LOT NUMBER COMBINATIONS. THE PART AND LOT NUMBER FOR THE CEMENT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSE CEMENT/BONE MANTLE FOR TIBIAL AND FEMORAL COMPONENTS. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SMARTSET CEMENT BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention