BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY 3 SYRINGEABLE CEMENT 40G

    MDR report key: 1933543 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10034
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    P960001/S005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED FOR THE CEMENT WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS 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 REOPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT CEMENT/BONE INTERFACE. DEPUY 3 CEMENT WAS USED AT THE TIME OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY 3 SYRINGEABLE CEMENT 40G 87LOD LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention