BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY CEMENT

    MDR report key: 1962422 · Received January 7, 2011

    Report

    Report Number
    1818910-2011-00408
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS PRODUCT AND LOT CODE REQUIRED FOR THE CEMENT WAS UNAVAILABLE. THE LOT NUMBER FOR THE FEMORAL COMPONENT IS UNK. A SEARCH OF THE COMPLAINT DATABASE FOUND TO PRIOR REPORTS FOR THE TIBIAL PART AND LOT NUMBER COMBINATION. 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

    THE PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL AND FEMORAL BETWEEN THE BONE AND CEMENT INTERFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization