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Depuy Hip

What Is The DePuy ASR™ XL Acetabular System?

The DePuy ASR™ XL Acetablular System is a metal-on-metal prosthetic hip replacement implant that was designed, manufactured, and/or sold by a subsidiary of Johnson & Johnson – DePuy Orthopaedics, Inc. (“DePuy”). The ASR™ XL Acetablular System is a ball and socket implant that consists of three components: the femoral stem, which is inserted into the femur, the femoral head (or ball), and the metal acetabular cup (or socket), which is what the femoral ball sits inside. The ASR™ XL Acetablular System was released in the market in July of 2003.

What Is The DePuy Pinnacle® Acetabular System?

The DePuy Pinnacle® Acetabular System is a ball and socket implant that consists of three components: the femoral stem, which is inserted into the femur, the femoral head (or ball), and the metal acetabular cup (or socket), which is what the femoral ball sits inside. Either a plastic, ceramic, or cobalt-chromium metal liner is placed on the inside of the acetabular cup. The DePuy Pinnacle® Acetabular System was released in the market in 2001.

What is the Recall?

On August 24, 2010, DePuy issued a recall for its ASR™ XL Acetabular System. According to DePuy, “data recently received by [DePuy] shows that more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery.” For a copy of the sample recall letter from DePuy to ASR™ patients, click here. For a copy of the recall letter to health care professionals, click here.

What Are Some Of The Symptoms Of A Defective ASR™ XL Acetabular System Or Pinnacle® Acetabular System?

Symptoms include pain, swelling, and problems walking. The symptoms could be a sign of:

  • Loosening of the implant (the implant does not stay attached to the bone in the correct position)
  • Fracturing of the bone around the implant
  • Dislocation of the implant (the two parts of the implant that move against each other are no long aligned)
  • Reaction to metal debris (soft tissue damage due to metal debris from the ball and socket components of the implant)

How Do I Know If I Have An DePuy ASR™ XL Acetabular System?

The DePuy ASR™ XL Acetabular System was first available in July 2003. You had to have had hip replacement surgery after July 2003. There are a couple of ways that you could find out whether you have an ASR™ XL Acetabular System. First, you may contact the health care professional that performed your hip replacement. For privacy reasons, the health care professional may ask that you inquire in person. Second, you may have been provided a card by the health care professional that performed your hip replacement surgery to provide to airport security that may identify the specific hip implant that you received.

How Do I Know If I Have A DePuy Pinnacle® Acetabular System?

The DePuy Pinnacle® Acetabular System was first available in 2001. You had to have hip replacement surgery in or after 2001. There are a couple of ways that you could find out whether you have a Pinnacle® Acetabular System. First, you may contact the health care professional that performed your hip replacement. For privacy reasons, the health care professional may ask that you inquire in person. Second, you may have been provided a card by the health care professional that performed your hip replacement surgery to provide to airport security that may identify the specific hip implant that you received.

What Should You Expect If You Do Have A DePuy ASR™ XL Acetabular System?

DePuy has told health care professionals that, for patients who received a recalled ASR™ XL Acetabular System, the health care professional should recommend that the patient return for a follow-up visit to determine how the ASR™ XL Acetabular System is functioning. At the follow-up visit, DePuy has advised health care professionals to:

For patients with an ASR™ XL Acetabular System that are NOT currently experiencing symptoms of a defective ASR™ XL Acetabular System:

  • Perform a blood test to test the metal ion levels
  • Advise their patients with the ASR™ XL Acetabular System that he/she follow-up with the health care provider annually for a clinical assessment and radiological evaluation for five consecutive years after the ASR™ XL Acetabular System was implanted (medical monitoring)
  • If at any time the metal ion levels are elevated past 7 ppb, then DePuy is suggesting that a MRI or ultrasound scan is performed to reveal any negative soft tissue reactions, fluid collections, or tissue masses
  • If there are no negative soft tissue reactions, fluid collections, or tissue masses, but the metal ion levels are elevated past 7 ppb, then a second metal ion test should be performed three months later
  • If there are any negative soft tissue reactions, fluid collections, or tissue masses, then DePuy is suggesting that revision surgery be considered

 

For patients with an ASR™ XL Acetabular System that are currently experiencing symptoms of a defective ASR™ XL Acetabular System:

  • Perform an X-ray. An X-ray will allow the health care professional to evaluate how the ASR™ XL Acetabular System is positioned, if there is any damage to the bone and if the ASR™ XL Acetabular System has remained attached to the bone
  • If the x-ray shows problems with your ASR™ XL Acetabular System, then DePuy is suggesting that revision surgery be considered
  • Perform a blood test to test the metal ion levels (the levels should be 7 parts per billion (ppb)
  • Perform an MRI or ultrasound scan to reveal any negative soft tissue reactions, fluid collections, or tissue masses
  • If there are any negative soft tissue reactions, fluid collections, or tissue masses, then DePuy is suggesting that revision surgery be considered

Please note that the above are only recommendations that DePuy has provided to healthcare professionals to test the condition of a DePuy ASR™ XL Acetabular System. Ultimately the decision of what tests are necessary to test the condition of your DePuy ASR™ XL Acetabular System, and the results of such tests should be left up to your physician. For example, DePuy has provided a 7 ppb threshold for cobalt and/or chromium levels, but your physician may determine that lower levels of cobalt and/or chromium may indicate a failing ASR™ system. Furthermore, DePuy under the recall may only reimburse you for treatment that reaches the recommendations provided by DePuy. The damages that you may incur as a result of DePuy’s recalled and defective ASR™ XL Acetabular System may be more than what DePuy is offering in the recall. If you have a DePuy ASR™ XL Acetabular System and you are experiencing any pain, swelling, and/or problems walking that you associate with your hip replacement system, then you should see your doctor.

What Should You Do If You Do Have A Pinnacle® Acetabular System?

If you have a Pinnacle® Acetabular System and you are experiencing any pain, swelling, and/or problems walking that you associate with your Pinnacle® Acetabular System, then you should see your doctor. Your doctor may determine that blood tests or other testing should be done to test the condition of your DePuy hip implant. The tests that your doctor may perform include:

  • Perform an X-ray. An X-ray will allow the health care professional to evaluate how the Pinnacle® Acetabular System is positioned, if there is any damage to the bone and if the Pinnacle® Acetabular System has remained attached to the bone
  • If the x-ray shows problems with your Pinnacle® Acetabular System , then your physician may suggest that revision surgery be considered
  • Perform a blood test to test the metal ion levels
  • Perform an MRI or ultrasound scan to reveal any negative soft tissue reactions, fluid collections, or tissue masses
  • If there are any negative soft tissue reactions, fluid collections, or tissue masses, then your physician may suggest that revision surgery be considered

What To Expect From Revision Hip Surgery.

Revision hip surgery requires the removal of the ASR™ XL Acetabular System or the Pinnacle® Acetabular System, the cement, the surrounding tissue and the dead bone before a new prosthesis can be inserted.

Postoperative care for revision hip surgery is the same as that for total hip replacement surgery. Patients should receive a combination of home health care, physical and occupational therapy home health care and other forms of rehabilitation.

Complications from this procedure, in addition to the risks associated with any major surgery, are similar to those for original joint replacement surgery. However, the success rate for revision surgery is usually lower than that for the original surgery because the bone is weaker. Complications from revision hip surgery include:

  • Infection
  • Loosening of the implant (the implant does not stay attached to the bone in the correct position)
  • Bone fractures during or after surgery (since the bone is weaker and there many be considerable scar tissue around the joint)
  • Dislocation (the two parts of the implant that move against each other are no longer aligned – twice as common as for a primary procedure)
  • One leg shorter than the other
  • Bone loss in the joint

If the joint is infected, then it might be surgically removed and re-implanted with antibiotic filled cement. In addition, intravenous (IV) antibiotics might be necessary for six to eight weeks, followed by at-home trea™ent of antibiotics.

For The DePuy ASR™ XL Acetabular System – How Is The Testing, Medical Monitoring, And/Or Revision Surgery Being Paid For?

In DePuy’s Information to Patients paper and Recall Notice to health care professionals, DePuy has represented that it will not advance costs for the testing, medical monitoring, and/or revision surgery associated with the recalled ASR™ XL Acetabular System. However, DePuy has stated that it “intends to cover reasonable and customary costs of monitoring and trea™ent for services, including revisions, associated with the recall of” the ASR™ XL Acetabular System. DePuy has recommended that fees for services related to the recalled ASR™ XL Acetabular System should be submitted to payors in the usual manner. Furthermore, before DePuy will reimburse you for reasonable and customary costs for the testing, medical monitoring, and/or revision surgery associated with the recalled ASR™ XL Acetabular System, the patient with the recalled ASR™ XL Acetabular System must validate that it has a recalled ASR™ XL Acetabular System and the completion and submission of required documentation, including a release to provide the patient’s confidential patient information to DePuy.

DePuy has hired a third-party claims processor (Broadspire Services, Inc.) for claim assessment and reimbursement processing associated with the DePuy ASR™ XL Acetabular System recall. To assist patients who have a DePuy ASR™ XL Acetabular System Broadspire will provide the patient a claim number and a letter of payment authorization. If you have a DePuy ASR™ XL Acetabular System, then SLChapman LLC may be able to assist you with the claims process.

Please note that it is still unclear what DePuy intends to reimburse you for under the recall. For instance, DePuy may only reimburse you for trea™ent that reaches the recommendations and/or advice provided by DePuy. The damages that you may incur as a result of DePuy’s recalled and defective ASR™ XL Acetabular System may be more than what DePuy is offering in the recall. These damages may include compensation for lost wages, pain and suffering, or continuing disability caused by the ASR™ XL Acetabular System. The recall does not provide any compensation to victims for these legally available damages. It is clear that the recall of the ASR™ XL Acetabular System will cause those affected to incur substantial damages, and the experienced lawyers at SLChapman LLC will work to obtain the maximum award provided under the law.

For The Pinnacle® Acetabular System – How Is The Testing, Medical Monitoring, And/Or Revision Surgery Being Paid For, And How SLChapman LLC Can Help?

If you have a DePuy Pinnacle® Acetabular System, then you will be responsible for all costs for testing, medical monitoring, and/or revision surgery. DePuy has not issued a recall for its Pinnacle® Acetabular System. However, if you suffer from pain, swelling, and problems walking associated with loosening of the Pinnacle® Acetabular System, fracturing of the bone around the Pinnacle® Acetabular System, dislocation of the Pinnacle® Acetabular System, or a negative reaction to metal debris from the Pinnacle® Acetabular System, then you may have a strong legal position that warrants additional analysis. At SLChapman LLC, we understand that the damages you have suffered or will be caused to endure as a result of a faulty Pinnacle® Acetabular System far exceed the costs of replacement, and we will work to obtain the maximum award provided for under the law. If you would like help regarding the DePuy Pinnacle® Acetabular System, then please contact SLChapman LLC for a free initial consultation. E-mail SLChapman LLC at hip@slchapman.com, or call (800) 550-2106 today.

For The DePuy ASR™ XL Acetabular System – How SLChapman LLC Can Help?

Since July 2003, thousands of people have had a recalled and defective ASR™ XL Acetabular System surgically implanted. As a result, many people with an ASR™ XL Acetabular System have suffered from pain, swelling, and problems walking associated with loosening of the implant, fracturing of the bone around the implant, dislocation of the implant, or a negative reaction to metal debris from the implant. If you or a loved one has suffered from one of these conditions, then you may have a strong legal position that warrants additional analysis. At SLChapman LLC, we understand that the damages you have suffered or will be caused to endure as a result of a faulty ASR™ XL Acetabular System far exceed the costs of replacement, and will work to obtain the maximum award provided for under the law. You can do so by contacting the experienced lawyers at SLChapman LLC for a free initial consultation. Email SLChapman athip@SLChapman.com, or call (800) 851-5523 today.

If There Has Already Been A Recall, Then Why Do I Need A Lawyer?

The damages that you may incur as a result of DePuy’s recalled and defective ASR™ XL Acetabular System may be more than what DePuy is offering in the recall. DePuy has represented that DePuy “intends to cover reasonable and customary costs of monitoring and trea™ent for services, including revisions, associated with the recall of” the ASR™ XL Acetabular System. However, DePuy has made no offer to pay any of the other damages caused by a faulty ASR™ XL Acetabular System that are available under the law. These damages may include compensation for lost wages, pain and suffering, or continuing disability caused by the ASR™ XL Acetabular System. The recall does not provide any compensation to victims for these legally available damages. It is clear that the recall of the ASR™ XL Acetabular System will cause those affected to incur substantial damages, and the experienced lawyers at SLChapman LLC will work to obtain the maximum award provided under the law.

What Is The Status Of The Lawsuits Regarding The Recalled DePuy ASR™ XL Acetabular System?

Recently, the panel on Multi-District Litigation (“MDL”) approved the centralization of many of the cases regarding the recalled DePuy ASR™ XL Acetabular Hip replacement system in the Northern District of Ohio (In re: DePuy Orthopaedics, Inc. ASR™ Hip Implant Products; Case No. 10-MD-2197) before Judge David A. Katz (“Federal DePuy ASR™ MDL”). In deciding to create the Federal DePuy ASR™ MDL, the panel on MDL found that the cases “involve common questions of fact, and the centralization [of the cases] will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”

Typically, multiple cases with common questions of fact are consolidated for pretrial purposes only. In other words, the cases are consolidated into a single jurisdiction for pre-trial motion practice and discovery. At the conclusion of pre-trial motion practice and discovery, each individual case will transfer to the jurisdiction in which it was originally filed, or to a “federal district of proper venue…based upon the recommendations of the parties to that case.”

The Federal DePuy ASR™ MDL is currently in its early stages. The Court has issued preliminary case management orders and has conducted status meetings between the Plaintiffs’ committees and Defendants. On March 25, 2011, preliminary discovery in the Federal DePuy ASR™ MDL was initiated.

Are There Lawsuits Regarding the DePuy Pinnacle® Acetabular System?

DePuy has yet to issue a recall of its Pinnacle® hip replacement system. However, reports indicate that there have been over 1,300 reported complaints, and several lawsuits have been filed regarding the Pinnacle® system. On March 25, 2011, a plaintiff filed a petition with the MDL panel to consolidate the DePuy Pinnacle® lawsuits with the Federal DePuy ASR™ MDL. A hearing is set for May 16, 2011 in Kentucky to hear the motion to consolidate the DePuy Pinnacle® lawsuits with the Federal DePuy ASR™ MDL.