May 17, 2011
On May 6, 2011, the FDA issued postmarket surveillance orders to manufacturers of Metal-on-Metal (MoM) total hip replacements marketed in the United States. Exponent is uniquely qualified to assist device manufacturers in the development and implementation of their post-market surveillance plans, including analysis and reporting of findings.
Our professionals have extensive experience in orthopaedic device design, materials, manufacture and commercialization; implant toxicology; epidemiology; biomechanics; human factors; and regulatory affairs.
Exponent can provide a variety of services related to the 522 order related to MoM devices.