Pharmaceutical

Months after worldwide recall, FDA approves another DePuy artificial hip

A ceramic artificial hip system made by DePuy Orthopaedics has been approved for marketing by the Food and Drug Administration (FDA). DePuy’s new Ceramax Ceramic Total Hip System is a ceramic-on-ceramic artificial hip replacement system that is surgically implanted to completely replace a hip joint that is painful or cannot function because of arthritis, injury or dislocation. The system could replace another type of artificial hip implant made by DePuy, which was recalled last August after reports that the devices were failing at a higher than expected rate.

DePuy’s new device consists of a metal hip stem that a doctor places into a hole drilled in the end of the thigh bone; a biolox delta ceramic, ball-shaped part (femoral head) that attaches to the hip stem; a metal, socket-shaped part (acetabular shell) implanted into the pelvis that the femoral head fits into; and a Biolox delta ceramic insert that fits into the acetabular cup. The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move. It is designed to relieve pain and allow for increased function in the hip.

DePuy had introduced the ASR hip replacement system five years ago claiming the metal design made the implant stronger and thus more durable over time than traditional ceramic implants. However, the metal parts were causing some patients problems. Reports showed the devices were loosening from the bone, fracturing the bone, and even dislocating after five years or less. Most hip implants can last a lifetime.

There were even reports that the rubbing together of the metal parts of the DePuy device caused bits of metal to leach into the bloodstream, leading to a type of blood poisoning known as metallosis.

DePuy ultimately issued a recall of nearly 100,000 hip replacement systems, including the ASR XL Acetabular System and the ASR Hip Resurfacing System.