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hip-recall-lawyer.com 164 articles

Hip replacement systems recalled

Johnson & Johnson, in conjunction with its DePuy Orthopaedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the parts. An estimated 93,000 people will be affected by Johnson & Johnson’s latest product recall.

Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System, and the DePuy ASR Hip Resurfacing System. Physicians were notified about potential problems with the hip replacement parts beginning in March 2011. The decision to recall the parts was made when the results of a new study confirmed a five-year rate of revision surgery of about 12 percent for the ASR resurfacing system and about 13 percent for the ASR XL system, according to DePuy, which is higher than the expected rate.

Subsequent data released in 2011, also from the National Joint Registry for England and Wales (NJR), showed even higher failure rates for DePuy’s ASR hip implants: 17 percent in patients who had their implants for five years and 29 percent for patients who had the devices for six years.

Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. These symptoms may indicate serious problems, including:

• Loosening – when the implant does not stay attached to the bone in the correct position
• Fracture – where the bone around the implant may have broken
• Dislocation – where the two parts of the implant that move against each other are no longer aligned.

Please contact your orthopaedic surgeon to determine whether you received a DePuy ASR hip implant. If you don’t know who performed your hip replacement surgery, ask your primary care physician or the hospital where the surgery took place.

New study advises surgeons, patients avoid all-metal hip implants

A new study funded by the National Joint Registry of England and Wales and published this month in the British medical journal The Lancet calls on surgeons to stop using metal-on-metal hip implants completely, saying that evidence shows patients who receive the implants are much more likely to need revision surgery to have the implants repaired or replaced. The study’s authors analyzed data from the National Joint Registry of more than 400,000 hip replacements made from 2003 to 2011. While the vast majority of those surgeries involved traditional implants made of plastic or ceramic, more than 31,000 patients received metal-on-metal ... Read More

DePuy ordered phase-out of defective hip implant after FDA inquiry

Johnson & Johnson decided to phase out one of the hip implants made by its subsidiary DePuy Orthopaedics and sell off its inventory shortly after receiving an inquiry from the Food and Drug Administration (FDA) that questioned the device’s safety and efficacy. The federal agency was asking the drug and medical device manufacturer for safety data on its metal-on-metal ASR XL Acetabulator hip replacement and hip resurfacing systems, and informed the company that blood tests in patients who had received the implants showed “high levels of metal ions.” The latest news adds more concern that DePuy and Johnson & Johnson ... Read More

Consumer Reports warns of FDA’s fast-track medical device approval process

In an email blast to one million subscribers, Consumer Reports President Jim Guest wrote that medical devices that receive U.S. Food and Drug Administration (FDA) approval through its fast-track process have created a “nightmare scenario” for public safety. The fast-track approval process, or 510(k), is a shortcut designed to speed low- and moderate-risk medical devices to market when their designs are similar to already approved devices, bypassing costly and time-consuming clinical safety trials. The majority of Class I and Class II medical devices, including DePuy Orthopaedic’s ASR hip implants, gained FDA approval through the 510(k) process. The ASR XL Acetabular ... Read More

Consumer Reports chief protests medical device approval process

“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to one million Americans earlier this year. He was warning consumers that medical devices they assume are safe may not be fully vetted before being approved by the Food and Drug Administration (FDA), and that the federal government needed to change this process that is putting the lives of millions of people at risk. Guest was speaking out against a long-used practice of the FDA in which so-called moderate risk medical devices are approved quickly without testing to prove they are safe and effective if similar ... Read More

Another victim of recalled DePuy hip implant speaks out

Terri Wagner-Morley’s artificial hip seemed like an answered prayer. In just one year, she regained mobility lost from chronic arthritis, and was able to exercise again. She shed more than 50 pounds and was enjoying life again. “It felt great,” she told the Star Tribune. But shortly thereafter problems began to surface. It started with a popping sensation in her right hip, then came the pain. Soon, Terri wasn’t moving around like she had been. The exercising stopped, and the weight came back. Terri’s artificial hip failed. She needed surgery to remove the defective device. An infection set in, which ... Read More

New Zealanders who say they were injured by DePuy hip implants find hope in UK litigation

A group of New Zealanders allegedly harmed by metal-on-metal hip implants manufactured by DePuy Orthopaedics is joining an international lawsuit against the company. According to Farifax NZ News, about 30 New Zealanders learned they were eligible to sue DePuy under English law and are currently working with a barrister (lawyer) in the U.K. to file their claims in the British court. Their eligibility comes as good news to all 507 New Zealanders who have been implanted with one of DePuy’s recalled ASR (articular surface replacement) hip devices, which have been implanted in about 93,000 patients worldwide. The plaintiffs are not ... Read More

DePuy hip implant leads to renewed pain, hardship for Minnesota woman

Terri, a mother of twin college-age daughters and a grown son, told the Minnesota StarTribune that the DePuy ASR artificial hip she received in 2008 to counter the chronic arthritis in her right hip gave her a new lease on life. As she recovered from replacement surgery, the pain subsided and her mobility improved dramatically. The increased activity allowed Terri to shed excess weight, and she went from 219 pounds to 165 in just a year. But in late 2009, her right hip popped, the pain came back, and all her progress stopped. In fact, she found herself sliding backward ... Read More

Study indicates metal-on-metal hip implants prone to failure

Surgeons should stop using metal-on-metal hip implants because they are prone to failure and may seep toxic metals into patients’ blood, say researchers who conducted safety studies on various hip replacement systems. The study was published this week in The Lancet. Hip implants are traditionally made with plastic or ceramic parts. But newer models have been designed with all metal parts. The all-metal devices have made news in recent months because of reports of early failures and blood poisoning from the metal components. Determining the failure rate is practically impossible in the United States because there is no joint registry. ... Read More

Study aims to find better, safer materials for hip implants

Researchers at the University of Limerick are gathering preliminary data on artificial joints in hopes of improving the lifespan of orthopaedic devices including artificial hips. About 750,000 surgeries to implant orthopaedic joints are performed each year in the United States, and that number is expected to climb to 4.5 million by 2030. Artificial hips are valuable devices for improving mobility and easing pain and discomfort for patients with hip joints damaged by osteoarthritis, rheumatoid arthritis, injury or other conditions. Typically, hip implants can last up to 20 years or more with about 13 percent failing prematurely. These traditional hip implants ... Read More

Patients with all-metal hip implants should be monitored yearly

The United Kingdom’s health regulator is recommending that patients who have received hip replacement systems made from all-metal parts be monitored once a year for as long as they have the implant. The news comes just after the British Medical Journal (BMJ) and the British Broadcasting Company (BBC) announced the results of a joint investigation into problems with the medical devices. Traditional hip implants are made with ceramic or plastic parts, but newer hip devices have employed an all-metal design built to hold up better over time. However, they appear to to be less durable than traditional implants. The flaw ... Read More