BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 3193576 · Received June 25, 2013

    Report

    Report Number
    1226188-2013-00049
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 5, 2013
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED HIP PROSTHESIS INCLUDED ACETABULAR COMPONENTS FROM ANOTHER MANUFACTURER. THE LABELING INCLUDED WITH THE OMNI COMPONENTS IMPLANTED (OMNI DOCUMENT IFU-008 REVISION D) STATES "THE APEX HIP SYSTEM CERAMIC HEADS ARE MODULAR CERAMIC HEADS FOR USE WITH THE APEX HIP SYSTEM STEMS AND THE APEX INTERFACE ACETABULAR SYSTEM." SERUM SAMPLES FROM THE PATIENT WERE ANALYZED FOR METALLIC IONS WITH THE RESULTS BEING: TITANIUM: 47 UG/L, CHROMIUM: 0.7 UG/L, COBALT: 3.8 UG/L. AT THIS TIME THERE ARE NO KNOWN THRESHOLD LIMITS FOR ION LEVELS. DURING THE REVISION SURGERY THE PSEUDO TUMORS WERE EXCISED AND BIOPSIED. THE BIOPSY RESULTS INDICATED THAT NO METALLOSIS WAS FOUND IN THE TISSUE. BOTH THE SERUM AND BIOPSY RESULTS WERE COMMUNICATED TO AN OMNILIFE REPRESENTATIVE WHO WAS PRESENT FOR THE REVISION SURGERY. THE IMPLANT WAS NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD ONLY USE THE IMPLANT USAGE TICKET INFORMATION TO CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THIS INFORMATION, A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED A HIP REVISION SURGERY DUE TO PRESENCE OF PSEUDO TUMORS IN PATIENT. THE SURGEON REMOVED THE HIP PROSTHESIS AND REPLACED WITH A HIP SYSTEM FROM ANOTHER MANUFACTURER. THE PROSTHESIS REMOVED INCLUDED AN OMNI FEMORAL HEAD, STEM, AND NECK. THE OMNI ACETABULAR COMPONENTS WERE NOT USED. THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288936 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNILIFE SCIENCE, INC. 8629

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention