DePuy Gains Supplemental Approval for Ceramic Hip

After years of controversy over its metal-on-metal hip implants, Johnson & Johnson subsidiary DePuy Orthopaedics Inc. has received supplemental approval from the U.S. Food and Drug Administration (FDA) for its ceramic-on-ceramic hip implant. The Ceramax total hip system was originally approved in 2010, but the FDA has now added approval for a 36 mm ceramic femoral head and related components, according to a safety and effectiveness summary notice released by the FDA.

The Ceramax ceramic total hip system’s ball and socket are both made from ceramic. The system does include some metal components, but unlike DePuy’s ASR device, the two sections that wear against each other are not made of metal and ostensibly does not present the same problem of metal deposits in patients’ bloodstreams.

The Ceramax system consists of a metal hip stem that a doctor places into a hole drilled in the end of the femur; a Biolox Delta ceramic, femoral head (ball) that attaches to the hip stem; a metal, acetabular shell (socket) implanted into the pelvis that the ceramic insert fits into; and a Biolox Delta ceramic insert that fits into the acetabular shell. Biolox Delta is a ceramic manufactured by Ceramtec, a ceramics company based in Germany.

The FDA summary clarified that the Ceremax hip system should only be used in patients who need replacement of a hip joint that is painful or cannot function because of arthritis, injury or dislocation. The system is not appropriate for skeletally immature patients, patients with active infections, patients with rheumatoid arthritis, among others.

“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, [Center for Devices and Radiological Health] believes that it is reasonable to conclude that the benefits of the use of the 36 mm DePuy Ceramax ceramic total hip system for the target population outweighs the risk of surgery when used in accordance with the directions for use.”

Alongside this report, the FDA also published a guidance brochure for reference. The brochure details the results of two recent trials conducted on the hip system, which show that the most common adverse event reported for the 28 mm implant size was thigh fracture (2.8 percent of participants). Difficulty of getting the ceramic liner to fit in place was reported for 2.3 percent of participants, and 1.1 percent of participants experienced a break in the ceramic liner. The 36 mm size saw less of these problems, but 3.6 percent of patients who received the larger size experienced inflammation of the tissues covering the upper thighbone (bursitis).