BEUDAMED
    FDA Adverse Event Summary report: N

    X-ALT HIP

    MDR report key: 3012761 · Received March 20, 2013

    Report

    Report Number
    1644408-2013-00163
    Date Received
    March 20, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON (B)(6) 2013 WAS DUE TO AN INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2013. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRADICTIONS THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENTS INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THAT THE REPORTED DEVICES RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE OR WERE PUT THROUGH AN ACCEPTABLE HYDROGEN PEROXIDE GAS PLASMA STERILIZATION PROCESS. ALL PARTS WERE WITHIN THEIR EXPIRATION DATE AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THE REPORTED COMPONENTS USED IN THE ORIGINAL SURGERY MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. DUE TO THE SHORT TIME BETWEEN THE ORIGINAL SURGERY AND THE REVISION, IT IS POSSIBLE THAT THE INFECTION WAS ACQUIRED IN THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THAT THE PATIENT WAS NOT COMPLIANT WITH POST SURGICAL INSTRUCTIONS. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THE INFECTION WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO AN INFECTION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115893 X-ALT HIP LINER / NON-HOODED - NEUTRAL, MP6 LPH ENCORE MEDICAL, L.P. 53919101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 411-00-000, LOT A1000000| 497-34-000, LOT A1000004