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.
Specifically, Exponent can provide the following services related to the 522 order related to MoM devices:
Compose strategic elements of manufacturer’s postmarket surveillance plan in response to FDA, execute manufacturer’s post-market surveillance program, and generate critical report elements upon completion of the clinical studies and retrieval analyses.
- Assist with identification of CLIA-certified laboratory for analysis of serum and whole-blood cobalt-chromium ion levels.
- Analyze, interpret, and report findings from toxicological analysis of laboratory findings.
- Propose methods for conducting both cross-sectional and prospective clinical studies to identify rates of adverse events associated with MoM THR that leverage existing manufacturer, clinical site, and THR registry data.
- Manage relationships with CROs engaged for prospective patient follow-up.
Analyze, interpret, and summarize data obtained from post-market analysis of manufacturers MoM THR post-market surveillance programs.
- Establish, implement, and manage an explant retrieval program to characterize in vivo mechanisms of bearing surface wear, trunnion wear, and corrosion (if any).
- Conduct retrieval analysis of MoM THR explants to include tribological, metallurgical, elemental and dimensional analysis of each explant.
- Review clinical medical records including radiographic analysis, identification of contributing factors, and biomechanical evaluation.