Tuesday, August 13, 2013

FDA to Conduct Study on Metal-on-Metal Hip Implant Corrosion

HealthPoint Capital


In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA issued a proposed order in January that required metal-on-metal (MoM) hip arthroplasty implant manufacturers to submit premarket approval applications. This course of action came about as a mounting body of evidence demonstrated MoM systems have failed prematurely and have instigated severe tissue and bone damage as a result of tiny particles of metallic debris released during artificial joint movement.

Just recently, the FDA has cited a “renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements,” and therefore is commissioning a study to investigate the relationship between volumetric wear and corrosion in total hip replacements and any potential link to clinical outcomes.

The study, which is estimated to take two years to conduct, will examine 250 explanted MoM hip replacements of various sizes and genders and use the American Society for Testing and Materials (ASTM) protocol for corrosion testing to analyze them.

The objective of the project is to generate a peer-reviewed journal article explaining correlations between wear and corrosion and relevant parameters (e.g. implantation time, lateral offset, head size, materials, and modularity), which will further help develop test methodologies and special controls for preclinical studies of total hip implants.

The FDA noted new design changes like MoM bearings, larger femoral heads and modular designs have reintroduced the issue even as the new features more closely approximate patient features.
The FDA is currently seeking private sector contractors to help it design and conduct the study.

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