BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMA HIP

    MDR report key: 3800180 · Received May 8, 2014

    Report

    Report Number
    1644408-2014-00270
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 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 REVISION WAS THE STEM ROTATED AFTER 1.5 MONTHS IN VIVO. NO INFORMATION WAS REPORTED ABOUT PATIENT ACTIVITIES DURING REHABILITATION, OR REGARDING BONE CONDITION SUCH AS CANCELOUS BONE STRUCTURE, OR OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE HOSPITAL KEPT THE DEVICE PER HOSPITAL POLICY AND IT WAS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT AND THAT ALL CRITICAL DIMENSIONS AND SPECIFICATIONS WERE MET WHEN RELEASED FROM DJO SURGICAL. THE ROOT CAUSE FOR THE EVENT MAY HAVE BEEN DUE TO BONE LOSS AND/OR POOR BONE QUALITY, OR THE SELECTION OF AN INAPPROPRIATELY SMALL DISTAL STEM DURING PRIMARY SURGERY. THE SELECTION OF A SIZE 18 STEM DURING THE REVISION SURGERY, WHEN A SIZE 14 STEM WAS SELECTED DURING THE PRIMARY SURGERY, REPRESENTS AN INCREASE OF TWO SIZES AND SUGGESTS THAT THE PRIMARY STEM WAS INAPPROPRIATELY SMALL FOR THE PATIENT'S ANATOMY. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Additional Manufacturer Narrative · 1

    HOSPITAL KEPT ITEM PER HOSPITAL POLICY.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE STEM ROTATING WITHIN THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279273 LIMA HIP LIMA REVISION DISTAL STEM 14 X 200MM LWJ ENCORE MEDICAL, L.P. 1212721

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 428-01-090, LOT 1106805