Hip Replacement Surgery
In the hip you were born with, the thigh bone, or femur and head, connects to the pelvis at the joint. The femoral head slides into the acetabulum (like a ball and socket). Within the acetabulum, the head rotates and moves, but sometimes that movement can be painful if you've withstood an injury, or some other condition that has caused a loss of mobility. Often, the only real treatment would be a total hip replacement (where both the ball and socket are completely replaced) or a hip resurfacing system (a partial replacement). Metal-on-metal hips were thought to provide the greatest range of motion, a very attractive quality to those in the market for a new hip.
With a total hip replacement, something called an acetabular cup is placed inside the acetabulum, and the femoral head is replaced with a metal ball, which is connected to a stem that is placed inside the femur. With the hip resurfacing system, the acetabular cup is placed inside the acetabulum, but instead of the entire head being replaced, a simple cap is placed over it.
What Brought You Here
A manufacturing defect and subsequent voluntary recall of the DePuy ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. If your doctor replaced your hip with a metal-on-metal hip (which offers great range of motion), then chances are you probably have the DePuy. If you're not sure what your hip is made out of or which hip your doctor used, call him or her immediately and find out. The first DePuy hip was used in July 2003, so if you got your hip replaced before then, you can breathe a sigh of relief.
If you do have the DePuy hip, read on.
Warsaw, IN, (August 26, 2010) – DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a revision surgery.
New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the ASR™ Hip Resurfacing System and approximately 13 percent for the ASR™ XL Acetabular System. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. Previous post-market surveillance data from a variety of sources – including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.
"We regret that this recall will be concerning for patients, their family members and surgeons," said David Floyd, president, DePuy Orthopaedics. "We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall."
The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.
DePuy has notified the U.S. Food and Drug Administration and other regulatory agencies globally of the voluntary recall.
Who Brought You here
Johnson & Johnson. The mega health care products and pharmaceutical manufacturer owns DePuy Orthopaedics, the subsidiary organization that makes and sells the DePuy ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System.
Symptoms You May Have
Pain, swelling, difficulty walking — caused by loosening (hip won't stay attached to the bone), fracture (broken bone), or dislocation (the pieces of the hip are no longer aligned). Loosening, fractures, and dislocations are often caused by metallosis, when metal particles come loose in the body and bloodstream as a result of the parts of the hip rubbing together. However, the fact that you are not experiencing any of these symptoms, unfortunately, does not mean you have nothing to worry about. New data suggests that the failure rate of the DePuy ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System may be as high as 40 to 50 percent. Thus, it may be in your best interest to seek help now, even if you are asymptomatic, or symptom free.
In The News
- Hip Replacement Recall By DePuy Orthopaedics Is Big News
- Two Hip Replacement Implants Recalled
- J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say
- Hip implant firm DePuy sued by more than 100 patients
What This Means For You
1. Order your medical records to confirm that your hip was replaced with the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System.
2. See your doctor. Discuss your medical history. Explain your symptoms if you have any. Order the medical records of that doctor's visit. An X-ray may tell your doctor the positioning of your hip, damage to the bone, and the hip's attachment to the bone. All patients, whether symptomatic or asymptomatic, should consider a blood test to test the metal ion levels. If the levels are above 7 ppb, you are likely experiencing failure of the DePuy ASR™ XL Acetabular Hip System or DePuy ASR™ Hip Resurfacing System and may need more extensive treatment.
3. Sign up to file a claim against Johnson & Johnson with Clark, Love & Hutson. Everything you've suffered in this process, or may still—the pain, the trauma of an additional surgery, the risk or adverse effects of going through a hip replacement a second time — wasn't your fault, and can't be satisfied with a simple replacement hip. Although DePuy publicly agrees to compensate patients for any medical treatment in regards to its faulty product, the company is paying the bare minimum and hasn't offered to pay for the intangible effects this defect has caused people like you. We, as a law firm well-versed in pharmaceutical and medical device litigation, can help. Signing up comes at no cost to you. Any attorneys' fees will come out of any settlement we are able to negotiate. You have nothing to lose. Contact us for more information.