2010: FDA Issues Class-1 Recall of DePuy ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System
Recently, a number of lawsuits have emerged surrounding the failure of metal-on-metal hip implants and hip replacement systems, particularly concerning the DePuy ASR™ XL Acetabular hip system and the DePuy ASR™ hip resurfacing system.
How the DePuy ASR™ and ASR™ XL Hip Replacement Systems Work
First, some information on how metal-on-metal hip replacements work from DePuy: “In a natural hip, the thigh
bone, known as the femur, is connected to the pelvis at the hip joint. The femur has a rounded end, called the femoral head. The femoral head fits like a ball into a concave surface on the pelvis, known as the acetabulum. For this reason, the hip joint is often called a ball and socket joint. The femoral head rotates within the acetabulum, which allows for motion. When osteoarthritis, injury or other conditions cause the hip joint to lose mobility and become painful, a hip replacement or hip resurfacing surgery may be performed.” (from page 16)
The DePuy ASR™ and ASR™ XL systems both contain a metal “ball” that is attached to the top of the femur, and a metal “cup” that lines the acetabulum, thus replacing a natural hip joint damaged by osteoarthritis or another condition.
Metal-on-Metal Hip Replacement Failure
In recent years, medical research has demonstrated these metal-on-metal hip replacement systems can fail in a number of ways. First, the replacement itself can fail to hold the normal weight of a person walking and can break. This was the reason the DePuy LPS “(Limb Preservation System) Lower Extremity Dovetail Intercalary Component” was recalled in 2013.
Further, with normal use, metal particles can wear off from the implants, in some cases causing metallosis (poisoning due to high levels of metal ions in the blood). Deborah Cohen of the British Medical Journal writes “Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium—the metals from which the implant was made—were also released into the blood and cerebral spinal fluid in some patients.”
Some research suggests that along with kidney and liver damage from metal ions in the blood, “occupational limits on ion levels are exceeded in a substantial proportion of [metal-on-metal hip replacement] patients and there is … evidence of increased cancer mortality.” Often, surgery is required to remove metal debris from the body and make corrective adjustments to the implant. Metal-on-metal hip replacements can also cause femoral fractures (breaking of the thigh bone), which is extremely painful and likely requires reoperation.
Other times, metal-on-metal hip replacements can suffer mechanical failure, wherein the hip replacement becomes out of line, thus causing a great deal of pain and requiring surgery to correct.
The DePuy ASR™ and ASR™ XL systems were first released in Europe in 2004, and by 2005 had made their way to the American market.
“By 2007, individual surgeons were not the only people noticing problems. The Australian National Joint Replacement Registry reported that the ASR had a high revision rate. The registry was set up to spot ‘outliers’—prostheses that have twice the rate of revision of others in their class. All hip prostheses fail in some patients, but it is expected that the rate will be about 1% a year. The Australian data showed a 5.16% (95% confidence interval 3.50% to 7.56%) revision rate at two years.”
Early American experience with the ASR hip replacement showed similar rates of complications: 3.1% in the first year of joint use alone.
DePuy ASR™ and DePuy ASR™ XL Recall
By the end of 2009, the ASR was recalled by DePuy in Australia, and “remained on the market in the rest of the world.” The British Medical Journal writes, “Confused by the apparent inaction by [UK regulators], in April 2010 a team from University Hospital of North Tees directly approached the agency to force it to acknowledge the problems associated with the ASR. By this time they were seeing a 15% revision rate at five years and almost all patients had tissue damage to some extent.” (emphasis added)
The worldwide 2010 DePuy ASR™ and DePuy ASR™ XL metal-on-metal hip replacement recall was based on the findings of a report by the National Joint Registry in the UK that found an overall revision rate for the DePuy ASR to be over 11%. To be clear, “revision” of a hip replacement system means surgical removal of the implant and replacement with a new one.
“In 2010, there were 76,759 hip replacement procedures recorded on the NJR, representing a 6% increase compared with the same reporting period last year. Of these, 68,907 were primary procedures and 7,852 were revision surgeries, representing a revision ‘burden’ of 11.4%.” (hyperlink added)
DePuy ASR™ and DePuy ASR™ XL Lawsuits
Due to the fact that DePuy was warned a number of times by surgeons and regulators alike of problems with the ASR hip systems but failed to act, the company now faces trial in Australia and has agreed to a $2.5 billion settlement in the United States to resolve “an estimated 8,000 cases of patients who had to have [the metal-on-metal ASR] hip implant removed or replaced.”
If you or a loved one used a DePuy ASR™ or DePuy ASR™ XL hip replacement system and suffered complications or required revision surgery, you may be entitled to significant financial compensation through an ASR lawsuit. For a free, no-obligation case consultation, contact our team of DePuy ASR hip replacement lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve, even from the largest of medical device manufacturers.
Call today and see how we can help.
(855) 452 – 5529
Also, every post we’ve written about DePuy ASR / DePuy ASRXL hip replacements is available here.