New Joint Registries Inspired by DePuy ASR Hip Implant RecallMay 3, 2011 | Parker Waichman LLP
It is hoped that two new joint registries being launched in the U.S. will shed light on how often artificial hip and knee devices experience premature failure. According to a report from Bloomberg.com, plans for the artificial joint registries were solidified in the wake of the DePuy ASR hip implant recall.
The artificial joint registries will track, among other things, the performance of metal-on-metal hip implants like the DePuy ASR hip implant, and a similar device, the DePuy Pinnacle hip implant. Recently, concerns have grown that such devices are more likely to fail early compared to traditional implants. The DePuy ASR hip implant was recalled last August, after data from a U.K. registry showed that within five years, 13 percent of ASR hips failed and needed to be replaced.
The DePuy Pinnacle hip implant, which is similar to the design of the ASR, has been named in lawsuits alleging it is more likely to fail early. Since the ASR recall was announced, more than 1,300 people have filed an adverse event report with the U.S. Food & Drug Administration (FDA) involving problems with a DePuy Pinnacle hip.
It is believed that the complications associated with metal-on-metal devices like the DePuy ASR hip implant and the DePuy Pinnacle hip implant are the result of wearing of the metal components, which can allow cobalt and chromium shavings to make their way into patients’ bloodstreams. This can cause cobalt poisoning, as well as a reaction known as metallosis, which can result in tissue breakdown, bone loss, and even the formation of non-cancerous tumors.
One of the two new joint registries will be run by the University of Massachusetts Medical School (UMass) and is funded by a $12 million grant from the Agency for Health Care Research and Quality, a division of the U.S. Department of Health Care and Human Services. It will track the experiences of more than 30,000 patients who undergo hip or knee implants each year, and its findings will be used to try to determine why some implants fail.
The other registry - the American Joint Replacement Registry (AJRR) – will be funded by orthopedists, prosthetic manufacturers (including Johnson & Johnson, which sold the ASR hip implant through its DePuy Orthopaedics unit), insurance companies and hospitals. According to Bloomberg, its goal is to track the more than 700,000 total hip and knee replacement surgeries that take place in the U.S. each year, and spot those that fail early. The AJRR registry began collecting data from 16 hospitals in December as part of a pilot program.
While registries like these are much needed, there is some concern that industry funding of the AJRR database will negatively impact its independence, Bloomberg said.