BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA HIP

    MDR report key: 3122613 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00276
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    PMA / PMN Number
    K082844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SERIOUS RISK TO THE PATIENT. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, 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 DISPOSED OF BY THE HOSPITAL AND 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 DEVICE RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE. 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 SHOWS THE REPORTED COMPONENTS USED IN THE ORIGINAL SURGERY MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT. THERE ARE MULTIPLE FACTORS NOT RELATED TO THE IMPLANT THAT CAN PLAY A ROLE IN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THE INFECTION THE PATIENT WAS SUFFERING FROM WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214547 DELTA HIP DELTA CERAMIC HEAD NEUTRAL LZO ENCORE MEDICAL, L.P. 871B1022

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention