DePuy Hip Replacement: ASR Hip System

On August 24, 2010, Johnson and Johnson subsidiary DePuy Orthopaedics, a division of Johnson & Johnson, issued a voluntary recall of the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System.

If you have one of these hips and have pain or weakness in the joint or are experiencing other symptoms, contact your doctor immediately. Those not experiencing any symptoms should still plan to consult with their doctors promptly, and on an ongoing basis annually.

We can help you understand your legal rights quickly and easily with a free, no obligation consultation.

Symptoms

While not all symptoms indicate a problem, you should take note of any unusual symptoms and all patients, regardless of symptoms, should follow up with regularly with their doctors. Even asymptomatic artificial hips may require revision:

Pain

Pain may be centralized at the joint or be felt in the leg, lower back, or elsewhere. Pain may be general and constant, or may occur specifically during movement (walking, sitting, standing, etc.).

Unusual sounds

Popping, clicking, grinding, or crunching sounds; unusual noises are often heard during movement of joint.

Inflammation, Swelling

Like pain, swelling may appear at the location of the implant or in the groin area surrounding the implant. Immediately after recovery, some inflammation is to be expected, but after recovery has occurred, unexplained swelling at the joint can be cause for concern.

Weakness

Weakness is often noted by patients who are having trouble walking or moving; some patients described having to lift their leg into position with their arms, having difficulty in starting a movement, or feeling the joint is not in place or is going out of place (sensation of dislocation).

Other

Other symptoms may include nausea, vomiting, fever, diarrhea, or headache. Increased levels of metal ions in the blood (from metal shed off the implant) can affect the heart, nerves, thyroid gland, and kidneys, causing such symptoms as chest pain, shortness of breath, numbness, fatigue, vertigo, memory loss, changes in vision or hearing, tinnitus, changes in urination, and other symptoms.

Issues & Injuries

Some of the issues and injuries associated with the ASR hip include:

Loosening of the implant

The metal components of the implanted device may loosen from the bone in which it's impanted.

Loosening of the joint

The cup and ball of the joint may loosen as a result of edge-loading or uneven wear, positioning, or for no immediately discernable cause.

Joint dislocation

Beyond simply loosening, the ball may become misaligned from or completely pulled out of the cup. Tendons may be ruptured.

Bone fractures

An increased fracture rate of the femur is considered one of the factors that held the ASR resurfacing device back from achieving FDA approval.

Infection

Infection may arise from a variety of causes.

Metal debris injuries

Metallosis, ALVAL, "metal poisoning," and a host of other names describe the injures caused by metal debris sloughed off these metal-on-metal hip implants.

"It is one of the biggest disasters in orthopaedic history"

When the ASR hip systems made by DePuy Orthopaedics were recalled in late summer 2010, it was viewed by many as too little, too late. Plagued by problems almost from the moment they hit the market, March 2011 numbers indicate that about half of these devices will fail within six years. A far cry from the 15 years hip replacements are expected to last.

That the ASR device reached the market at all is attributable in part to high medical device profits, the competition for valuable marketshare, and loopholes in the approval procedure. A lack of tracking mechanisms, the inability of at least certain regulators to act, and the power manufacturers wield over the fate of their products all contributed to the ASR remaining on the market as long as it did.

Unfortunately, it is now patients who are paying the price. Read more about the history of the DePuy ASR hip replacement system recall.

The heading quotation is from an investigative report for the British Medical Journal on the ASR. The reports opens: "It is one of the biggest disasters in orthopaedic history, according to one senior surgeon" (Cohen).

I have an DePuy Replacement Hip, what are my rights?

Your rights may vary based on several factors. To address your specific issues, please contact us for a free, no obligation consultation. We can review the details of your case and tailor our answers specifically to you. Call 1-800-471-3980 today or send us an email.

Sources

1. Metal-on-metal hip implants. FDA.gov. <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm>. Accessed October 6, 2011.
2. Statement by the President of the British Orthopaedic Association and the British Hip Society Executive Committee: Large Diameter Metal on Metal Bearing Total Hip Replacements. British Hip Society & British Orthopaedic Association. March, 2011. (PDF)
3. Cohen, Deborah. "Out of Joint: The story of the ASR," British Medical Journal. http://www.bmj.com/content/342/bmj.d2905.full. May 14, 2011.

Why are these hip replacements being recalled?

For failing at rates more than double (and by some indications, far greater than double) the rate other hip replacement systems are failing.

How do I know if I have a DePuy hip replacement being recalled?

Contact your physician or the hospital where your surgery was performed.

How do I know if my hip is failing?

Regular testing, including imaging of the hip and blood ion levels, should be completed by your doctors. This is true regardless of your symptoms, but should be of special concern if you are suffering symptoms (including pain, swelling, difficulty walking, etc.).

I'm asymptomatic, what should I do?

Contact your doctor for an examination of your hip and blood ion levels. The BHS and BOA recomends that asymptomatic patients with satisfactory test results be followed up with annual appointments. If you don't have any adverse symptoms, but tests show component wear, loosening, or elevated blood ion levels, testing should be repeated every 2-6 months, with a careful evaluation of the implant for deterioration.

Also, consider speaking with a lawyer. Why? Because statutes of limitations (in many areas just two years) may run out.

DePuy says it will pay my costs, do I need a lawyer?

First, it's important to note that you can speak with one of our lawyers for free, with no obligation to sign on, about your case and the unique aspects that may affect the outcome.

Second, DePuy's interest are in limiting their costs. Their version of "reasonable costs" may vary widely from yours and your family's.

Finally, most law firms take cases on a contigency basis, meaning no money is required out-of-pocket from you; instead, attorneys take their fee from costs recovered.

To sum up, there is nothing to loose and everything to gain by contacting one of our lawyers before signing anything with DePuy.