On August 26, 2010, DePuy Orthopedics, a unit of Johnson & Johnson, announced the recall of its hip implants known as the ASR XL Acetabular and ASR Hip Resurfacing systems due to a defect in the design making it extremely difficult for even the best surgeon to properly implant the cup in a position that ensures long-term functioning. The DePuy ASR hip was implanted in 93,000 patients worldwide.The DePuy hip recall follows years of complaints that the DePuy ASR hip was failing in patients, requiring costly and painful revision operations. Recent studies show that up to one in eight patients may be forced to undergo revision surgery due to a high early failure rate with the DePuy ASR artificial hip.
Orthopedic specialists believe that DePuy’s design of the hip replacement cup is the reason for the failures. DePuy’s cup is shallower than some other hip implants, and that may be the reason why DePuy’s ASR system has such a high failure rate. The cup also has a close clearance between the ball and the cup which makes it prone to excessive wear. The cup must also be installed at a very specific angle (45 degrees) by the surgeon or it may not perform properly and be prone to failure. DePuy has known for years that DePuy’s ASR hip system might be more of a challenge to implant properly than similar hip implants made by other companies
On August 26, 2010, after selling 93,000 of the defective products, DePuy finally released shocking information that shows that 13 percent of patients with the ASR hip implant have had to have the implant removed due to a failure. It is believed among attorneys representing individuals with Depuy ASR hip implants that the percentage is actually much higher. Based on this data, DePuy escalated its recall of the ASR hip implants and told hospitals and doctors to immediately stop implanting the devices and to return them to the company. The true failure rate of the DePuy ASR may climb much higher in the coming years as doctors and their patients come to realize that their implants are failing.
Metal-on-Metal Design
The DePuy ASR is a metal-on-metal hip replacement system put on the US market in 2003. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. DePuy ASR hip implants are metal-on-metal in design containing Cobalt and Chromium. Metal debris from these implants may be causing the following adverse health effects:
- Metallosis – the metal shavings may cause pain, loosening, fluid masses, tissue necrosis, and bone loss (osteolysis).
- Aseptic Lymphocyte Vasculitis- Associated Lesion (ALVAL)- which is a localized hypersensitivity to the metal wear debris which may result in groin pain, loosening, osteolysis, dislocations and fractures.
- Cobalt or Chromium Poisoning- may cause pain, blindness, deafness, heart failure, peripheral neuropathy, diminished cognitive function and memory loss.
- Pseudotumors – fluid-filled or solid masses around the implant which may reemerge until metal is removed from the body.
- Cancer- Cobalt and Chromium are essential parts of body chemistry; however, excessive levels caused by wear debris from implants may have serious effects in high enough levels over long periods of time. Laboratory animals exposed to high levels of Chromium and Cobalt have developed cancer. Theoretically humans are at risk as well.
Hip Implant Failure Claims
You must first determine if you have a recalled Depuy ASR hip implant. Many people have already received a letter from their surgeon advising them that they have one of the recalled hip implants. Some individuals have a card which shows which implant they have. If you do not know which implant you have, call your orthopedic surgeons office and request a copy of your surgery report which will show the name of the manufacturer and the model of your hip implant. We will be glad to review those records for you to confirm that you have the recalled hip implant and may have a potential claim.
If you do have a recalled hip implant you should consult your surgeon regarding what course of treatment he recommends. Even if you are not having serious symptoms you should consult with an attorney to determine your rights. If you are having symptoms from your hip implant you should schedule a comprehensive diagnostic exam to find the cause of the symptoms and plan an appropriate course of treatment. Due to the fact that the implant causes potential metal poisoning from wear you should have your blood checked for levels of Chromium and Cobalt that maybe coming from the defective hip implant. This is a simple test your family doctor or your surgeon can order. Request the blood test results and send them to us for review so we may advise you if they are excessive and cause for concern.
On its Website, DePuy says that it “intends to cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall.” However, it appears this promise of reimbursement comes with strings attached. Payment for doctor’s costs, X-rays and any repair surgery is conditional on the patient agreeing to provide DePuy with all medical records, as well as the faulty hip implant. Patients must agree to sign a consent form to this effect. This form gives Depuy unlimited access to all your medical records.
Keep in mind these are the same people who are responsible for marketing and selling the defective implant who want you to “work with them”. They want you to trust them so they can take possession of the most critical pieces of evidence in your case-the hip implant. It is important to recognize that their program only mentions paying the cost for treatment which your own insurance does not pay. It mentions nothing regarding compensating people for pain , suffering, mental anguish, loss wages and the fact that you may have to have additional revision surgeries because of the need to have the current implant removed early.
DePuy’s patient information sheet states that although signing the Medical Release Form is not required, “without access to all of the appropriate medical information, it is unlikely that we will be able to consider the patient’s claims for reimbursement and prompt resolution of their claim may not be possible.”
We believe that it is inappropriate that the original hip replacement and medical records would come under the control of DePuy, as doing so could hamper your product liability claims against the device maker. Recipients of the recalled ASR hip implant should not sign anything given to them by DePuy without first consulting an attorney. It is also critically important that the original hip replacement be preserved as evidence. Before the implant is removed your doctor and the hospital should be instructed to preserve the implant and give it to you. It is your property and belongs to you. For our clients we handle the contact with the hospital and doctors and give them a specific protocol to follow regarding handling the removed implant. We also have experts who can then test and analyze the failed implant for your case.
The Moody Law Firm is currently representing people nationwide who are victims of the DePuy hip implant recall. If you or a loved one is a victim of DePuy’s hip implant recall, you may be entitled to recover damages in a lawsuit against the manufacturer. Please contact us.
