ASR Hip System recall guide for patients

 

To ASR Hip Replacement Patients:

At DePuy, meeting the needs of patients is at the center of what we do, and everyone at DePuy is united by the common goal of improving patients’ lives. DePuy puts patients first. If DePuy finds that a product is not meeting its high standards and the needs of patients, 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In August 2010, DePuy issued a voluntary recall of our ASR™ Hip System after receiving new, then-unpublished data from a joint replacement registry in the UK.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 2010 data indicated that while most patients with the ASR Hip System had not required additional hip surgery, the rate of ASR patients who needed a second surgery, called a revision surgery, was not in line with data previously reported in that registry.

These systems first became commercially available in July 2003 both globally and in Australia. If you had your hip surgery prior to July 2003, the hip you received is not subject to the ASR recall.

It is important for all ASR patients to have their hip evaluated by their doctor. Patient 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 committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary. DePuy will also address recall-related patient out-of-pocket expenses, such as lost wages and travel costs. ASR patients should contact the ASR Help Line at 1800 665 460 for assistance.

There are many different brands of hip implants available, including several brands from DePuy, 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. 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. If you have additional questions, please do not hesitate to call our ASR Help Line at 1800 665 460.

call the ASR help line
Callers should dial the toll-free number 1800 665 460. The call center will be active from 7.00 am – 7.00 pm, Monday through Friday.

The Reason for 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, including the ASR Hip System.

According to 2010 data from an independent national registry in the UK that tracks implant performance and outcomes, while most patients with the ASR Hip System had not required additional hip surgery, the rate of ASR patients who needed revision surgery was not in line with data previously reported in that registry. In a revision surgery, the existing hip implant is removed and is replaced with a new hip implant.

This 2010 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 in that registry.

After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System. The company acted quickly by voluntarily recalling the product in every country where it was sold.

Recent Data
The company monitors data about ASR from a variety of sources, including joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports. Currently, there is a range of data reported regarding ASR revision rates, and the company is examining why the revision rate for ASR is reported to be higher than for other metal-on-metal hips. For the most recent national joint registry data from the UK click here, and for the most recent national joint registry data from Australia click here.

Anatomy of the Hip
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
The ASR Hip System was one of many hip implants available from DePuy. The ASR Hip System is a one-piece cup and socket that was 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. 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 a DePuy ASR Hip Resurfacing System, a one-piece metal component known as an acetabular cup is placed in the acetabulum 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

Learn more about what to do if you think you are affected by this recall on the "What to do" tab.

 
 
 

Determining If You Have an ASR
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.

• 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.

Reimbursement Program
DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery, if necessary. DePuy will also address recall-related patient out-of-pocket expenses, such as lost wages and travel costs. ASR patients should contact the ASR Help Line at 1800 665 460 for assistance.

Learn more about the claims and reimbursements process on the "Reimbursement" tab.

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 additional testing or surgery to replace your hip implant.

• 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.

Learn about Claims & Reimbursements for Testing on the “Reimbursement” 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 committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.

 
 
 

Additional Program Information
The reimbursement process offers patients the benefit of highly professional customer support from Crawford Services, a specialised claims-processing company. The Crawford reimbursement program uses common, well-established claims processes developed specifically to make it easy for patients and health care providers to initiate claims, submit information and receive reimbursement. 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 Authorisation Form or providing medical information to DePuy.

To Submit Claims for Reimbursement and For Additional Questions
Call the ASR Help Line at 1800 665 460 to obtain a claim number and to get instructions on how to submit a claim for reimbursement. Please also call the ASR Help Line for answers to any additional questions you may have.

 
 
 
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