BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 1972430 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-01166
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    PMA / PMN Number
    K081163
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. PROVIDED INFO STATED THE CEMENT TECHNIQUE WAS A CONTRIBUTING FACTOR AND THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING DUE TO POOR CEMENT TECHNIQUE. THE IMPLANT ONLY HAD CEMENT ON THE POSTERIOR SURFACE. THE PEGS WERE CLEAN. THE CEMENT REMAINED BONDED TO THE BONE. DEPUY CEMENT WAS USED AT THE TIME OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMV 40G US EO 87MBB; 87LOD MBB DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention