BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORO TRI-LOCK FEM 10.0 STD NK

    MDR report key: 1071249 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02634
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDG
    PMA / PMN Number
    K830004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 15 YEARS AGO. EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR 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. 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

    PT WAS REVISED TO ADDRESS GROIN PAIN. OSTEOLYSIS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORO TRI-LOCK FEM 10.0 STD NK 87JDG JDG DEPUY ORTHOPAEDICS, INC. NA 643810

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention