BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 745432 · Received August 7, 2006

    Report

    Report Number
    1226188-2006-00006
    Event Type
    Injury
    Date Received
    August 7, 2006
    Date of Event
    July 25, 2006
    Report Date
    August 4, 2006
    Manufacturer
    OMNI LIFE SCIENCE
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 220210 SHORT 40 NECK, CATALOG NUMBER 333299, 32MM -4 ALUMINA HEAD. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    PAINFUL HIP, WITH LIMP, AND FEELING OF INSTABILITY, 3 YEARS AFTER TOTAL HIP ARTHROPLASTY. AT REVISION SURGERY, ALL DEVICE COMPONENTS INTACT, FEMORAL STEM FIXED WITH FIBROUS TISSUE ONLY, NO EVIDENCE OF BONE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS COATED FEMORAL STEM LPH OMNI LIFE SCIENCE 6X14.5 STEM 312

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization