BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETMV MV ENDURANCE 40 G

    MDR report key: 1071277 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02846
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT; HOWEVER, PROVIDED INFO INDICATES A NON-RECOMMENDED TECHNIQUE OF PREPARING THE CEMENT WAS USED AND WAS A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING SURGERY, THE CEMENT HARDENED TOO QUICKLY RESULTING IN A 35 MIN DELAY TO THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSETMV MV ENDURANCE 40 G 87LOD LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention