BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 862130 · Received June 6, 2007

    Report

    Report Number
    1226188-2007-00005
    Event Type
    Injury
    Date Received
    June 6, 2007
    Date of Event
    April 23, 2007
    Report Date
    June 5, 2007
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 200410 APEX MODULAR MEDIUM 47.5 NECK, AND CATALOG NUMBER 16153 28L BIOLOX FORTE ALUMINA CERAMIC HEAD. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION. PHOTOGRAPHS OF EXPLANTED DEVICES PROVIDED BY INITIAL REPORTER INDICATE SHEAR FAILURE OF THE FEMORAL STEM COBALT CHROMIUM ALIGNMENT PIN AND FRACTURE OF THE LATERAL NECK PEG.

    Description of Event or Problem · 1

    POROUS FEMORAL STEM REVISED 65 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY, WITH EXTENDED TROCHANTERIC OSTEOTOMY. PRIOR TO REVISION, PATIENT FELL WHILE PLAYING TENNIS, RADIOGRAPH SHOWED SEPARATION OF THE MODULAR NECK FROM THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. 4X13 STEM 150

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention