BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 745423 · Received August 7, 2006

    Report

    Report Number
    1226188-2006-00005
    Event Type
    Injury
    Date Received
    August 7, 2006
    Date of Event
    June 15, 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

    OTHE DEVICES USED: CATALOG NUMBER 220605 LONG 45 NECK, CATALOG NUMBER 333235 32+4 ALUMINA HEAD. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF HIP INSTABILITY, LATERAL RADIOGRAPH SHOWED EVIDENCE OF NECK ROTATION. AT REVISION, COBALT CHROME ALIGNMENT PIN IN THE STEM WAS OBSERVED TO HAVE SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM LPH OMNI LIFE SCIENCE 6X14.5 STEM 313

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization