BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 3242263 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21872
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    PK081155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND ONE ADDITIONAL REPORT FOR THE CEMENT PART AND LOT NUMBER COMBINATION; HOWEVER, REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED NON-CONFORMANCES; MICRO AND STERILITY TESTS PASSED. THE RETAINED CEMENT SAMPLES WERE TESTED FOR DOUGH TIME, SETTING TIME, HANDLING CHARACTERISTICS AND MECHANICAL PROPERTIES; ALL WERE FOUND WITHIN SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE FEMORAL PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS PAIN, STIFFNESS, AND ASEPTIC LOOSENING OF THEIR FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342982 SMARTSET MV 40G - EO CEMENT LOD 9610921 DEPUY CMW 3144430

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention