professionals recall guide
The guide for healthcare professionals offers clinical detail about the ASR recall and provides help for answering patients’ questions.
Surgeon information
Call the ASR help line
Callers should dial the toll-free number 888-627-2677. The call center will be active from 8 a.m. to 9 p.m. EST, Monday through Saturday.
To ASR Hip Replacement Patients:
At DePuy, our mission for more than a century has been developing products and technologies that help patients who have been impacted by pain, disability and a loss of mobility return to a more active lifestyle. If DePuy finds that one of its products is not meeting the high standards of our company, our patients, or our surgeons’, we take appropriate action. In August 2010, DePuy issued a voluntary recall of our ASR™ Hip System after receiving new, then-unpublished data from a joint replacement registry in the UK. This data indicated that while the vast majority of patients with the ASR Hip System were not experiencing any problems, a higher number of ASR patients than previously reported to DePuy needed a second surgery, called a revision surgery, earlier than expected.
It is important for all ASR patients to have their hip evaluated by their doctor, though most patients will not need additional surgery as a result of this recall.
Your safety and health are important to DePuy, and we are committed to providing ASR patients with the information and support they need for their recall-related medical care. DePuy is working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.
There are many different brands of hip implants available, including several brands from DePuy Orthopaedics, and patients may not be aware of what brand of implant they have. We encourage patients to check with their surgeon or hospital to determine what brand of hip implant they have received.
If you have an ASR Hip, please call our ASR Help Line at 1-888-627-2677 to have your specific questions answered and to begin the claims and reimbursement process. We know that the recall is concerning to patients and their families. With this website, we have aimed to provide detailed information about the recall and what it means for you. The U.S. FDA also recently provided information on metal-on-metal hips, such as the ASR Hip System, which can be found here
If you have additional questions, please do not hesitate to call our ASR Help Line at 1-888-627-2677.
Sincerely,
DePuy Orthopaedics
The ASR Hip System Recall
DePuy’s top priority is and always has been patient safety. With this priority in mind, we continually evaluate data on our products.
The ASR Hip System
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.
The ASR Hip System is one of many hip implants available from DePuy Orthopaedics. The ASR Hip System is a one-piece cup and socket that may be used either for total hip replacement or hip resurfacing.
ASR XL Total Hip Replacement
With an ASR XL total hip replacement, a one-piece metal component known as an acetabular cup is placed in the acetabulum as shown in the image below. The femoral head is replaced with a metal ball which is connected to a metal stem placed inside the femur.
An ASR XL System includes two components:
1. A metal femoral head (or ball) connected to the stem; and
2. A one-piece metal cup that lines the acetabulum
DePuy ASR Hip Resurfacing System With an ASR Hip Resurfacing System, a one-piece metal component known as an acetabular cup is placed in the acetabulum, as shown in the image below, and a metal cap is placed over the femoral head.
The DePuy ASR Hip Resurfacing System includes two components:
1. A metal cap is placed over the natural femoral head; and
2. A one-piece metal cup lines the acetabulum The ASR Hip Resurfacing System was only approved for use outside the U.S and was not commercially available in the U.S.
All components for the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing Platform are part of this recall.
Understanding the Reason for the Recall
The majority of ASR hip replacement surgeries have been successful, but according to data from an independent national registry in the UK that tracks implant performance and outcomes, more patients with ASR Hip System implants than previously reported to DePuy had undergone revision surgery. In a revision surgery, the existing hip implant is removed and is replaced with a new hip implant.
The UK data indicated that within five years of having an ASR resurfacing device implanted, approximately 12 percent of patients had revision surgery and that within five years of having an ASR total hip replacement, approximately 13 percent of patients had revision surgery, which was not in line with data previously reported to DePuy.
Based on these data and our commitment to patient safety, in August 2010, DePuy Orthopaedics voluntarily recalled its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. DePuy is working to provide patients and surgeons with the information and support they need.
Learn more about what to do if you think you are affected by this recall on the "What to do" tab
What to Do
The ASR Hip Systems first became available in July 2003. If you had hip surgery prior to July 2003, the hip you received is not subject to this recall. If you had hip surgery after July 2003, please contact your orthopaedic surgeon or the hospital where your surgery took place to determine whether you received an ASR Hip.
It may take time for the surgeon or hospital to locate this information for you. For privacy reasons, your orthopaedic surgeon or the hospital where your surgery took place may ask you to request this information in person.
Next Steps
If you do not have an ASR Hip:
The hip you received is not subject to this recall. Please speak to your orthopaedic surgeon about any questions you may have about your hip replacement.
If you do have an ASR Hip:
• Contact the DePuy ASR Help Line to initiate a claim with DePuy.
DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. ASR patients should contact the ASR Help Line at 1-888-627-2677 for assistance.
Learn more about the claims and reimbursements process on the "reimbursements" tab
• Schedule an appointment with your surgeon.
If you received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System, your surgeon will be able to evaluate how your ASR Hip System is functioning. Additional testing and treatment may be necessary to evaluate your hip implant.
Follow-up Care
It is important that you follow up with your surgeon, even if you are not experiencing symptoms, for evaluation of your hip implant. You should discuss with your surgeon how frequently you should return for an office visit if you are not experiencing symptoms.
In some cases, your surgeon may order additional blood testing or imaging to evaluate your hip. Your surgeon will determine the best care plan for you and discuss treatment solutions should they be needed. If you don’t know who performed your hip replacement surgery, ask your primary care physician or the hospital where the surgery took place.
Learn more about Testing on the "Testing" Tab
Symptoms & Causes
ASR patients who required revision surgery have reported a variety of symptoms before having the revision surgery, including pain, swelling and problems walking. These symptoms are not unusual immediately after hip replacement surgery. If the symptoms continue or come back, you should consult with your surgeon.
Possible Causes
Symptoms such as pain, swelling or problems walking might be caused by:
• Loosening
The implant does not stay attached to the bone in the correct position.
• Fracture
The bone around the implant may have broken.
• Dislocation
The two parts of the implant that move against each other are no longer aligned.
Testing
Diagnostic Testing will help your surgeon evaluate your hip and determine future treatment recommendations, if necessary.
What to Expect
Your surgeon may use one or more of several tests to evaluate your ASR Hip System:
• X-rays
X-rays will allow your surgeon to evaluate how the ASR Hip System is positioned, if there is any damage to the bone, and/or if the ASR Hip System has remained attached to the bone. If the x-rays show problems with your ASR Hip System, your surgeon may recommend surgery to replace it.
• Blood Tests
Your surgeon may order blood testing as part of your ASR Hip System evaluation. Your surgeon may recommend a second blood test to confirm the results of the initial blood test.
• MRI or Ultrasound
Your surgeon may want to do an MRI or ultrasound test of your ASR Hip System. Your surgeon may then recommend additional testing or surgery to replace your implant.
Paying for Testing
DePuy is working with many public and private insurers (including Medicare) to establish a single and simplified process to address claims for recall-related care and medical treatment.
Learn more about Claims & Reimbursements on the Reimbursements Tab
Treatment
Your surgeon will need to evaluate how your ASR Hip System is functioning and make a decision on the best course of treatment for your specific needs.
Learn more about testing and evaluation on the "Testing" tab
If Your ASR Hip Is Functioning Well
If you do not have any symptoms or test results that suggest you may need to have your implant replaced, then you should follow your surgeon’s recommendations for continued follow-up.
If Revision Surgery Is Necessary
If you need to have an additional surgery, your surgeon will select the appropriate implant system for you. The manufacturer and model of any replacement implant system is a choice that you and your doctor are best positioned to make. DePuy is working with many public and private insurers (including Medicare) to establish a single and simplified process to address claims for recall-related care and medical treatment, including revision surgeries.
Claims & Reimbursements
Your safety and health are important to DePuy, and we are committed to providing ASR patients with the information and support they need for their recall-related medical care.
DePuy is working with patients and their health insurers to address medical costs directly associated with the recall.
DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. DePuy has engaged an independent, third party claims processor, Broadspire, so that you may be reimbursed quickly and efficiently. In order to submit your claim and receive reimbursement for eligible costs associated with treatment, you will need to obtain a claim number by calling the ASR Help Line (1-888-627-2677). When you call the ASR Help Line, you will be instructed on how to submit claims for reimbursement.
We’d like to share some important information with you about Broadspire to explain the role of Broadspire in the reimbursement process and answer questions you may have. Please
click here to view a fact sheet.
It is important to note that patients do not waive the right to pursue legal action by initiating a claim for reimbursement, signing the Patient Authorization Form or providing medical information to DePuy.
Submitting Claims for Reimbursement
Call the ASR Help Line at 1-888-627-2677 to obtain a claim number and to get instructions on how to submit a claim for reimbursement.
Reimbursement for Out-of-Pocket Expenses
DePuy will cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. After you have initiated a claim through the ASR Help Line, please submit any requests for reimbursement for out-of-pocket expenses and costs you incur associated with receiving treatment to our third party claims processor, Broadspire.
Eligible costs for reimbursement may include:
• Medical treatment including testing, treatment, and revision surgery if required • Travel and hotel expenses related to treatment
• Lost wages related to missed work associated with treatment
Your claim will be processed, and you will be reimbursed as quickly as possible. Claims will be evaluated on a case-by-case basis.
Insured Patients
DePuy is working with many public and private insurers (including Medicare) to establish a single and simplified process to address claims for recall-related care and medical treatment, including revision surgeries. If you are an ASR patient who requires recall-related diagnostic testing and medical treatment and you have insurance, whether through a public or private insurer, please seek out the medical care that you need and submit those charges directly to your insurer for coverage as you normally would. We have provided physicians with a number of guidelines regarding available test and monitoring options and we continue to update these guidelines as new information comes to our attention.
Uninsured Patients
For patients without any insurance or health care coverage, please contact the ASR Help Line operated by Broadspire, an independent, third-party claims processor engaged by DePuy, at 1-888-627-2677 to determine the options that may be available to you and any of your treating providers.
More Information
Please call the ASR Help Line at 1-888-627-2677 for answers to any additional questions you may have.
