BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BONE CEMENT

    MDR report key: 1892442 · Received November 3, 2010

    Report

    Report Number
    1818910-2010-07849
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FOR THE CEMENT AS THE PART AND LOT CODE REQUIRED WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE FEMORAL AND TRAY PART AND LOT NUMBER COMBINATIONS. 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 ADD'L 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 IMPLANT/BONE INTERFACE OF BOTH TIBIAL AND FEMORAL COMPONENTS. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY BONE CEMENT BONE CEMENT LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention