BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ4 L

    MDR report key: 1892434 · Received November 3, 2010

    Report

    Report Number
    1818910-2010-07766
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    NJL
    PMA / PMN Number
    P830055/S111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. PROVIDED INFORMATION STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND SWELLING. FEMORAL AND TIBIAL LOOSENING WAS FOUND AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA PS CEM FEM SZ4 L 87NJL NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA EA4BR4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention