BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2931576 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00006
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K973119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REVISION SURGERY ON (B)(6) 2012 WAS DUE TO AN INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS 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 COMPONENT WAS EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THE DEVICE RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE. THE DEVICE WAS WITHIN ITS 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 THE COMPONENT 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 THE INFECTION WAS ACQUIRED IN THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE 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 - THE PT HAD AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30888 FMP HIP LINER-TO-DEGREE HOODED, MP9 LPH ENCORE MEDICAL, L.P. 53911280

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention