BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMA HIP

    MDR report key: 4243653 · Received November 11, 2014

    Report

    Report Number
    1644408-2014-00686
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LWJ
    PMA / PMN Number
    K092331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS A RESULT OF A PATIENT JOINT DISLOCATION AFTER 59 DAYS OF USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST THIS LOT NUMBER. THE EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE RESULT OF PATIENT DISLOCATION. NO OTHER CONDITIONS, ROOT CAUSE, RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PROXIMAL BODY ROTATING ON THE IMPLANTED STEM; THE PATIENT'S HIP DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727879 LIMA HIP LIMA REVISION BODY, LAT. 100MM LWJ ENCORE MEDICAL, L.P. 1306015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R