BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SMARSET MV ENDURANCE CEMENT

    MDR report key: 1930882 · Received December 14, 2010

    Report

    Report Number
    1818910-2010-09765
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TO SEARCH 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SMARSET MV ENDURANCE CEMENT 87 LOD LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention