DePuy Pinnacle Complaints: Are Metal-on-Metal Devices Too Risky?

Honolulu, HIAs the courts ready to hear lawsuits concerning the DePuy Pinnacle and other metal-on-metal hip replacement devices, a new report indicates that devices like the DePuy Pinnacle hip replacement may be more costly than they are worth. The DePuy Pinnacle and a similar product, the DePuy ASR hip replacement device, are the subject of lawsuits alleging that patients were harmed by use of the metal-on-metal devices.

Now, a report by The New York Times (08/22/11) says that thousands of complaints have been filed concerning all-metal hip devices. The New York Times analyzed data from the US Food and Drug Administration and reports that the agency received more than 5,000 reports about metal-on-metal hips since January 2011. That figure is more than all reports on metal-on-metal hips from 2007 through 2010. Among complaints are that the patient's hip implant has been or will be removed due to failure after only a few years.

"The mounting complaints confirm what many experts have feared—that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007," writers for The New York Times note.

Most of the complaints concerning metal-on-metal devices reportedly involved the DePuy ASR (Articular Surface Replacement). The article quotes one doctor as saying that using the all-metal hip devices is "like playing Russian roulette," because of the potential dangers.

Meanwhile, the paper notes that it found around 200 complaints about the all-metal version of the DePuy Pinnacle and 400 complaints concerning the Pinnacle that involved metal-related problems.

The Times reports that at one point, metal-on-metal devices made up approximately 33 percent of the hip replacement surgeries, although since a recall of the ASR and subsequent lawsuit filings, use of all-metal devices has plummeted to about five percent.

Among reported problems with the metal-on-metal devices are an unusually high failure rate and a risk of metallosis, a condition in which metal debris from the devices comes loose and is absorbed by the surrounding tissue. Earlier in 2011, the US Senate Special Committee on Aging (a video can be found on the committee's website; the hearing is called "A Delicate Balance: FDA and the Reform of the Medical Device Approval Process") heard testimony from a patient who had a DePuy ASR device implanted. The patient, Katie Korgaokar, testified that at the urging of her surgeon, she had blood tests done and learned that her cobalt and chromium levels were 1,000 percent higher than normal. At age 41, Korgaokar had revision surgery to replace the all-metal device.

All-metal hip implants were reportedly designed for young, active people because the devices were believed to be more durable than the traditional hip devices, which included a ceramic component. Because of the alleged failure of the devices, however, many patients are undergoing revision surgery much earlier than expected. While most hip devices are expected to last up to 15 years, some patients have revision surgery within five years. This could increase the chances that in their lifetime, they will have a second and even third revision surgery.

In addition to the pain that can accompany failure of a hip device, there are complications that can come with revision surgery, including a longer recovery time and limited mobility. Lawsuits have been filed concerning both the DePuy ASR and the Pinnacle. Although the ASR was recalled in 2010, there has not been a recall of the DePuy Pinnacle.