BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CEMENT

    MDR report key: 1496645 · Received September 30, 2009

    Report

    Report Number
    1818910-2009-05371
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO SEARCH THE COMPLAINT DATABASE BY MFG LOT WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS FEMORAL LOOSENING. OSTEOLYSIS WAS DISCOVERED INTRAOPERATIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention