FDA issued a final order requiring OEMs to submit a premarket approval application for certain metal-on-metal (MoM) total hip replacement devices, specifically hip joint metal/metal semi-constrained with a cemented acetabular component and hip joint metal/metal semi-constrained with an uncemented acetabular component.
FDA believes that there is insufficient evidence to conclude that general + special controls would provide reasonable assurance of the devices' safety and effectiveness. The devices will remain Class III, and PMA applications must be filed by May 18, 2016 to continue marketing an MoM total hip or to market a new one.
PMA applications must cite:
- Risks known, or that should be reasonably known, to the applicant
- Device effectiveness
- Full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought
Five manufacturers presently have clearance to market MoM hips in the U.S., and all have approved postmarket surveillance study plans:
- Biomet (now Zimmer Biomet)
- DePuy Orthopaedics
- Encore Medical (now owned by DJO)
- Wright Medical Technology
- Zimmer (now Zimmer Biomet
In 2013, Rob Packard and Jean Bigoney, Ph.D. penned a two-part primer for BONEZONE on metal implant test method results and risk analysis steps for OEMs to consider as fallout continued over the use of MoM implants.