Originally approved in December 2010, Ceramax is indicated for non-cemented use in adult patients undergoing total hip replacement. The implant contains some metal components, but is a break from the metal-on-metal hip implants that have mired the company in lawsuits and headlines since a recall in 2010.
The Ceramax implant features a metal hip stem, a ceramic femoral head, a metal acetabular shell and a ceramic insert that fits into the acetabular shell, according to the FDA approval notice. "The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move," the notice reads.
The latest supplemental PMA was submitted to include a new 36 mm ceramic femoral head and related components, according to the FDA safety & effectiveness summary.
"The clinical data in this application support the reasonable assurance of safety and effectiveness of the 36mm DePuy Ceramax Ceramic Total Hip System when used in accordance with the indications for use and indicated population," the FDA reported. "Therefore, CDRH believes that it is reasonable to conclude that the benefits of the use of the 36mm DePuy Ceramax Ceramic Total Hip System for the target population outweighs the risk of surgery when used in accordance with the directions for use."
In a patient guide published alongside the approval summary DePuy describes the Ceramax implant and its potential benefit over hips made of other materials, including the metal-on-metal, or MoM, implants that have been the focus of thousands of lawsuits nationwide and around the world.
"While there is no conclusive evidence that supports the benefits to patients of the DePuy Ceramax Ceramic Total Hip System over other artificial hips," according to the patient guide. "There are concerns with reports of serious adverse reactions in patients having Metal-on-Metal artificial hips. These adverse reactions are believed to be caused by the metal particles and/or metal ions coming from the metal bearing components."
In connection with the FDA’s premarket approval order, DePuy agreed to a 10-year follow-up post-approval study of 80 patients implanted with the 36 mm Ceramax device. DePuy further agreed to perform a single-arm post-approval study of 170 patients with follow-up at 6 weeks and every year for 5 years. The medical device maker lastly agreed to gather short, medium, and long-term data on Ceramax patients from the U.K. National Joint Registry and the Australia Orthopaedic Assn. NJRR, with 10-year post-op follow-up for all patients, according to the FDA approval letter.
DePuy and J&J are currently battling a slew of MoM hip implant personal injury lawsuits as well as a highly subscribed multi-district lawsuit proceeding in Ohio. The 1st bellwether trials in th DePuy MDL are slated to begin in June, having been postponed from their previous May 13 date.
Lawsuits against DePuy began piling up in June 2010 when a a Florida woman accused the company of knowing about the devices’ problems but failing to warn physicians. That suit was followed days later by 3 more from California residents who all had to have revision surgery after the implant partially detached from their hip sockets.
DePuy voluntarily recalled the ASR in August 2010 "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a company report. A report passed around internally in 2011, in the midst of the high-profile recall, concluded that 37% of DePuy’s ASR hip implants would require revision or replacement in less than 4.6 years.
Federal regulators in the U.S. have launched a probe into possible marketing violations for the ASR hip.