BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT CEMENTED STEM SZ3 STD

    MDR report key: 1822861 · Received August 25, 2010

    Report

    Report Number
    1818910-2010-05909
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K013352
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE REPORT STATES: LOOSENING OF THE FEMUR IS REPORTED; FEMORAL STEM SUBSIDENCE IN CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT CEMENTED STEM SZ3 STD NONE JDI DEPUY ORTHOPAEDICS, INC. NA YS9D71000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention