, , , , , , , , , ,

DePuy ASR Hip Implant Prompts Launch of Hip, Knee Registries

American Joint Replcament Registry images

The DePuy ASR hip implant recall has prompted two medical groups to set up databases to track the success and failure rates of hip and knee implants. According to a report from Bloomberg News, one of the two databases – 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. The second registry 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.

The AJRR registry began collecting data from 16 hospitals in December as part of a pilot program, Bloomberg said. The 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 to spot those that, like the DePuy ASR hip implant, are prone to premature failure.

At least one DePuy ASR hip implant plaintiffs’ lawyer told Bloomberg that he was concerned that funding being provided to the AJRR by the prosthetic industry could affect its independence.

The UMass registry will track the experiences of more than 30,000 patients who undergo hip or knee implants each year, Bloomberg said. Researchers hope to shed light on why some implants succeed and others fail.

Information gleaned from the two registries could be used to determine how prone metal-on-metal hip implants like the DePuy ASR implant are to early failure. As we’ve reportedly previously, DePuy announced the ASR recall last August, citing data from a U.K. registry that showed that within five years, 13 percent of its ASR XL Acetabular hips failed and needed to be replaced.

The DePuy ASR Hip Implant System is a metal-on-metal hip implant made of chromium and cobalt, consisting of a cup that’s implanted into the hip with a ball joint that connects to the leg. It is believed that many of the complications linked to the DePuy hip implant are caused by wearing of the metal components, which can allow cobalt and chromium shavings to make their way into patients’ bloodstreams. This can cause a reaction known as metallosis, which can result in tissue breakdown, bone loss, and even the formation of non-cancerous tumors. The shedding of metal shavings can also cause cobalt poisoning, a disorder that, if left untreated, can put patients at risk of tinnitus (ringing in the ears), vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cardiomyopathy, and hypothyroidism.

The DePuy ASR hip replacement is not the only metal-on-metal implant that has been connected to premature failures. A similar device, the DePuy Pinnacle hip implant, has recently been named in lawsuits that allege the device failed prematurely, and resulted in elevated levels of cobalt in the blood, permanent disability, severe and prolonged pain, and other complications. Such lawsuits also allege that the DePuy Pinnacle hip implant is substantially equivalent to the defective DePuy ASR hip implant. As we’ve reported previously, 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.

NewsInferno.com disclaimer: This article: DePuy ASR Hip Implant Prompts Launch of Hip, Knee Registries was posted on Tuesday, May 3rd, 2011 at 7:11 am at NewsInferno.com and is filed under Defective Medical Devices, Depuy.


Technorati Tags: US Joint Registry, US Hip Registry, US Knee Registry