BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BONE CEMENT

    MDR report key: 1801241 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05058
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED TO SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED LOOSENING BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT INFORMATION. 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

    PATIENT REVISED FOR OSTEOLYSIS, POLYETHYLENE WEAR OF INSERT AND PATELLA; AND LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. REVISION SURGERY FOUND LOOSENING AT THE BONE/CEMENT INTERFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention