BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY 3 SYRINGEABLE CEMENT 40G

    MDR report key: 2162330 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12070
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    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 PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS MALPOSITIONING OF THE TIBIAL TRAY, WHICH WAS ALSO LOOSE AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY. POLY WEAR OF THE TIBIAL INSERT AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY 3 SYRINGEABLE CEMENT 40G 87LOD LOD DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA VJ9AJ4000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention