BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS PC FEM STEM 18.5X200MM BOW

    MDR report key: 1210586 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04745
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K003182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF DISLOCATION. DURING THE SURGERY, THE SEGMENT AND STEM WOULD NOT DISENGAGE EVEN WITH THE INSTRUMENT CAUSING A 30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS PC FEM STEM 18.5X200MM BOW 87JDI & 87JWH JDI DEPUY ORTHOPAEDICS, INC. N/A CJ6DV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention