ASR Hip Replacement Recall Guide

For more information on the U.S. ASR Hip Settlement Program, please   click here
professionals recall guide
The guide for healthcare professionals offers clinical detail about the ASR recall and provides help for answering patients’ questions.

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To ASR Hip Replacement Patients:

At DePuy Orthopaedics, 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In August 2010, DePuy issued a voluntary recall of our ASR™ Hip System after receiving new, then-unpublished data from a joint replacement registry in the UK.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.

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.

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.

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. For general information about metal-on-metal hip implants, which includes the ASR Hip System, please visit the U.S. FDA’s website here.
If you have additional questions, please do not hesitate to call our ASR Help Line at 1-888-627-2677.

Sincerely,

DePuy Orthopaedics

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.

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 Orthopaedics. 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
 

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

The ASR Hip Resurfacing System was only approved for use outside the U.S and was not commercially available in the U.S.

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

The ASR XL Acetabular Hip System first became commercially available in the U.S. in December 2005. If you had hip surgery in the U.S. prior to December 2005, the hip you received is not subject to this recall. If you had hip surgery after December 2005, 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.

ASR Part Number List
ASR Part Number List

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:

•  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 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.

Paying for Testing
Broadspire evaluated requests for reimbursement related to medically necessary testing and related exams performed on or before August 24, 2015 for U.S. patients who had an ASR Hip System implant. Please refer to the "Reimbursement" tab for more information.

Learn more about Claims & Reimbursements 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.

Learn more about Claims & Reimbursements for treatment on the "Reimbursement" tab.

 
 
 

DePuy understands that the August 2010 voluntary recall of the DePuy ASR™ Hip Resurfacing System1 and the ASR™ XL Acetabular System has been concerning to patients, their family members and surgeons. Since the recall, DePuy’s efforts to inform and support ASR Hip System patients and their surgeons have been a top priority. DePuy also established a reimbursement program to address recall-related testing and treatment. This program has included reimbursement for recall-related revision surgeries and follow-up treatment, as well as other patient out-of-pocket expenses.

The reimbursement program, administered by Broadspire, a third-party claims processor, was intended to remove financial barriers for patients directly affected by the recall so they could receive recall-related testing and treatment. The program was the first of its kind worldwide, and it has, to date, resulted in thousands of payments on behalf of ASR Hip System patients globally. DePuy also provides reimbursement to insurers and third-party payors. In addition, DePuy has funded the U.S. ASR Hip Settlement Program to provide compensation to eligible patients that have undergone replacement of their ASR Hip.

It is important to note that patients do not waive the right to pursue legal action by initiating a claim for reimbursement through Broadspire, signing the Patient Authorization Form or providing medical information to DePuy.

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 through Broadspire.

U.S. Broadspire Program Dates

Note: All medical expenses should continue to be addressed through routine healthcare channels, such as public or private insurance. For reimbursement of out-of-pocket expenses, the following program eligibility dates apply.

For testing and related exams of ASR Hips

•  For U.S. patients who have an ASR Hip System implant, Broadspire evaluated requests for reimbursement related to medically necessary testing and related exams performed on or before August 24, 2015. Testing and exams performed after August 24, 2015 on patients who currently have an ASR Hip will not be considered for reimbursement by Broadspire. The August 24, 2015 program eligibility date applied to routine care and treatment incurred before, and separate from, a revision surgery.

For revision surgery and certain related expenses

•  For patients not eligible for the U.S. ASR Hip Settlement Program, reimbursement for the cost of ASR recall-related revision surgery to replace an ASR Hip, as well as certain patient out-of-pocket expenses, will continue to be addressed by Broadspire on a case-by-case basis if the revision surgery takes place within seven years of the initial ASR implantation surgery. As in the past, determinations will be based upon availability of clinical indications showing that the revision is related to the recall.

•  For patients not eligible for the U.S. ASR Hip Settlement Program, requests for reimbursement for testing and exams after recall-related revision surgery and associated patient out-of-pocket expenses will be addressed by Broadspire on a case-by-case basis for one year from the date of the revision surgery.

•  Please note, two settlement agreements have been announced to compensate eligible ASR patients in the U.S. who had revision surgery on or before January 31, 2015. Broadspire reimbursement is not available to patients who are eligible to participate in the U.S. ASR Hip Settlement Program. To learn more about the settlement program, please visit www.usasrhipsettlement.com.

ASR Hip System patients should continue to seek follow-up care according to their doctors’ guidance.

1 The DePuy ASR Hip Resurfacing System was only approved for use outside the U.S. and was not commercially available in the U.S.

 

 
 
 

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