DePuy Pinnacle: New Device Approved

Washington, DCDespite concerns about the DePuy Pinnacle hip replacement device, a new DePuy Pinnacle hip replacement has been approved for the market. Although there are reportedly lawsuits pending concerning the Pinnacle hip replacement, the US Food and Drug Administration (FDA) has given DePuy Orthopaedics, a subsidiary of Johnson & Johnson, the go-ahead to market a new Pinnacle device.

The new Pinnacle hip replacement is different from the previous version because the newer version will be a ceramic-on-metal design. The older DePuy Pinnacle is a metal-on-metal design, which has been linked to serious health problems. Although the DePuy Pinnacle remains on the market, a different metal-on-metal device from DePuy, the ASR hip replacement, was recalled in 2010. That recall was announced after reports of unusually high failure rates in the device.

In addition to lawsuits concerning the ASR device, DePuy reportedly faces 57 lawsuits concerning the Pinnacle. Those lawsuits have been consolidated into a multi-district litigation for pre-trial proceedings. Lawsuits against DePuy allege the company knew about problems with its hip implants but allowed them to remain on the market.

Among concerns about metal-on-metal hip devices are that metallic debris can come loose from the device through normal wear and tear and be absorbed into the patient's bloodstream and surrounding tissue. That can result in high levels of metals, including cobalt and chromium, in the patient's system and can ultimately cause failure of the hip replacement device.

The new Pinnacle device will be called the Pinnacle CoMplete Acetabular Hip System. It is reportedly the first hip replacement system to use a ceramic ball and metal socket. The FDA approved the device after a two-year clinical trial that found no difference between patients who received the ceramic-on-metal device and those who received a metal-on-metal device.

Signs that a hip replacement device has failed include pain in the hip, limited mobility and difficulty moving. For some patients, the only sign that something is wrong is a blood test that shows high levels of cobalt or chromium. Patients who experience a hip replacement failure may require revision surgery to replace the failed device. With each revision surgery, the chances of complications increase.