Case Studies

Total Knee Replacement Modeling. People whose knee joints have degenerated due to arthritis, trauma, or disease frequently suffer from potentially debilitating knee pain. In many of these cases, total knee replacement surgery can restore the patient to a normal lifestyle. With 90 percent of replacement knees still functioning after 10 years, the surgery is being performed more often on younger, active people. For this reason, Exponent is investigating the longevity of knee replacements.

The primary concern for knee replacements over a lifetime of normal use is wear of the metal replacement joint. Exponent analyzed the wear experienced by the polyethylene tibial component of the artificial knee. Working with the Materials and Mechanics practice, the Biomechanics practice used the small punch test (previously used for characterizing the in-service performance of metallic structures) to evaluate differences in material degradation in different areas of the component.

Needle Incineration Device. Inadvertent needle sticks represent an enormous risk to health-care professionals. Several different approaches have been suggested to minimize this risk. A manufacturer with a prototype design and manufacturing process used Exponent's services to minimize the time required for safety and efficacy testing and Pre-Market Approval (PMA) by the FDA. Exponent, working closely with the R&D and manufacturing engineers, corporate officers, and attorneys, developed a series of device safety and clinical efficacy tests and helped the company defend this strategy at the first FDA meeting on this device. Exponent then completed many of the test protocols and performed a hazard analysis (design FMEA). The FDA approved the PMA in record time.

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