BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT CEMENTED STEM SZ7 STD

    MDR report key: 1131129 · Received August 20, 2008

    Report

    Report Number
    1818910-2008-03496
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K013352
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF A FRACTURED BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT CEMENTED STEM SZ7 STD 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA B33G91000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention