Hip replacement common topics; surgery, recovery, total hip, anterior hip, recovery time, symptoms, lawsuit.

Depuy ASR Hip System

The FDA has received many reports of the acetabular component of the Depuy ASRT Hip cup loosening and moving, requiring revision surgeries on patients.

If you have been injured as a result of a Depuy ASRT Hip Replacement product, you may be eligble for compensation and should contact a lawyer for injury who specializes in product liability litigation and medical device injury torts.

Depuy also voluntarily recalled a batch of hip replacement products on July 17, 2010, a Class 2 Recall of the DePuy ASR 100 Acetabular Implant, 48 mm.

Depuy Company Background

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care.

These companies are unified under one vision – Never Stop MovingT – to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.

Depuy ASRT Hip Cup Recall

The company voluntarily recalled the product in August of 2010.

What parts have been recalled?

All components for the ASRT XL Acetabular System and DePuy ASRT Hip Resurfacing Platform from DePuy Orthopaedics, Inc. are part of this recall.

How does the hip work?

The hip joint is like a ball that fits in a socket. The socket portion of the hip is called the acetabulum. The femoral head at the top of the thigh bone (femur) rotates within the curved surface of the acetabulum. With an ASR Hip, a one-piece acetabular cup which is a metal liner replaces the acetabulum. With an ASR XL total hip replacement there are three components: the femoral stem is inserted inside the femur, the femoral head (or ball) connects to the stem and then fits inside the acetabulum. Once the three components are aligned, more natural movement may be restored. With the DePuy ASR Hip Resurfacing system there are two components: a cap is placed over the natural femoral head and the acetabulum is replaced with the one-piece cup.

Why has there been a recall?

Data recently received by the company 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. New data shows that five years after implantation, approximately 12% of patients (1 in 8) who had received the ASR resurfacing device and 13% of patients (1 in 8) who had received the ASR total hip replacement needed to have a revision surgery.

Depuy ASR Voluntary Hip Cup Recall Press Release

DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASRT XL Acetabular System and DePuy ASRT Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a revision surgery.

The majority of Depuy ASR Hip Replacement surgeries have been successful. However, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12% for the ASRT Hip Resurfacing System and approximately 13% for the ASRT XL Acetabular System. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients.

Previous post-market surveillance data from a variety of sources – including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.

“We regret that this recall will be concerning for patients, their family members and surgeons,” said David Floyd, president, DePuy Orthopaedics. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”

DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.

DePuy is providing hospitals, surgeons and patients with comprehensive information about the recall to help them determine next steps. Patients and health care professionals with questions related to this recall should visit depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by calling 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients in other countries can place a collect call to the U.S. at +1 813-287-1651 24 hours a day, seven days a week.

The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASRT Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASRT XL Acetabular System was first launched in 2004 and has been available worldwide.

Very few devices remain on the worldwide market. DePuy decided in 2009 that it would be discontinuing the ASR System as a result of declining demand and the intention to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.

DePuy has notified the U.S. Food and Drug Administration and other regulatory agencies globally of the voluntary recall.

Sulzer Orthopedics – Hip Replacement Joints

Why did Sulzer Medica recall the Hip Replacement Joints?

Sulzer Medica disclosed that a “mineral-oil based lubricant” was found on the surface of the recalled Inter-Op® shells. In some patients, this lubricant has prevented proper bonding of the prosthesis with the patient’s own surrounding bone and tissue causing joint instability and severe pain. Sulzer had reported that 129 people had undergone required revision surgery by mid-January, 2001. However, that number has now increased to 573 as of March 1, 2001.

Sulzer Orthopedics Inc. has now received adverse reports concerning one of its artificial knee parts. Though the manufacturer is not recalling the product, it did withdraw it from the market in March due to a problem with one of the parts of the knee
prosthesis called the tibia baseplate. About 1,300 people in the United States have received the knee part so the potential problem with the knee part is far smaller in scope than the problem with the Inter-Op hip prosthesis.

How can I find out what type of hip prosthesis was used in my hip replacement surgery?

Ask your doctor or surgeon and to give you a written confirmation of what type and model of hip replacement prosthesis was used in your surgery (or surgeries).

What is a hip replacement?

Hip replacement, or arthroplasty, is a surgical procedure in which the diseased parts of the hip joint are removed and replaced with new, artificial parts. These artificial parts are called the prosthesis. The goals of hip replacement surgery are to improve mobility by relieving pain and improve function of the hip joint.

Why do people have hip replacement surgery?

The most common reason that people have hip replacement surgery is the wearing down of the hip joint that results from osteoarthritis. Other conditions, such as rheumatoid arthritis (a chronic inflammatory disease that causes joint pain, stiffness, and swelling), avascular necrosis (loss of bone caused by insufficient blood supply), injury, and bone tumors also may lead to breakdown of the hip joint and the need for hip replacement surgery.

Who should be done prior to considering hip replacement surgery?

Before suggesting hip replacement surgery, the doctor is likely to try walking aids such as a cane, or non-surgical therapies such as medication and physical therapy. These therapies are not always effective in relieving pain and improving the function of the hip joint. Hip replacement may be an option if persistent pain and disability interfere with daily activities. Before a doctor recommends hip replacement, joint damage should be detectable on x rays.

What pre existing health problems may complicate hip replacement surgery?

For some people who would otherwise qualify, hip replacement may be problematic. For example, people with chronic diseases such as those that result in severe muscle weakness or Parkinson’s disease are more likely than people without chronic diseases to damage or dislocate an artificial hip. Because people who are at high risk for infections or in poor health are less likely to recover successfully, doctors may not recommend hip replacement surgery for these patients.

What are alternatives to total hip replacement?

Before considering a total hip replacement, the doctor may try other methods of treatment, such as an exercise program and medication. An exercise program can strengthen the muscles in the hip joint and sometimes improve positioning of the hip and relieve pain.

What does hip replacement surgery involve?

The hip joint is located where the upper end of the femur meets the acetabulum. The femur, or thighbone, looks like a long stem with a ball on the end. The acetabulum is a socket or cup-like structure in the pelvis, or hipbone. This “ball and socket” arrangement allows a wide range of motion, including sitting, standing, walking, and other daily activities.

During hip replacement, the surgeon removes the diseased bone tissue and cartilage from the hip joint. The healthy parts of the hip are left intact. Then the surgeon replaces the head of the femur (the ball) and the acetabulum (the socket) with new, artificial parts. The new hip is made of materials that allow a natural, gliding motion of the joint. Hip replacement surgery usually lasts 2 to 3 hours.

Sometimes the surgeon will use a special glue, or cement, to bond the new parts of the hip joint to the existing, healthy bone. This is referred to as a “cemented” procedure. In an uncemented procedure, the artificial parts are made of porous material that allows the patient’s own bone to grow into the pores and hold the new parts in place. Doctors sometimes use a “hybrid” replacement, which consists of a cemented femur part and an uncemented acetabular part.

Hip Implant Replacement

The FDA has received many reports of the acetabular component of the Zimmer Durom cup loosening and moving, requiring revision surgeris on patients.

Contacting an Attorney

If you have been injured as a result of a Zimmer Durom cup for Hip Replacement product, you may be eligble for compensation and should contact a personal injury law firm who specializes in product liability litigation and medical device injury torts. Zimmer has had troubles with it’s hip parts in the past and were forced to recall another product in 2001 because the product was disintegrating.

Zimmer Company Background

Zimmer is a worldwide leader in joint replacement solutions for knee pain and hip pain, and provides comprehensive spine care solutions for acute and chronic back pain. The company also provides a broad range of trauma, dental implant, and orthopaedic surgical products. Founded in 1927, Zimmer is committed to providing effective techniques in hip replacement and knee replacement for orthopaedic surgeons who restore mobility and relieve the pain of osteoarthritis and traumatic injuries. Our minimally invasive hip and minimally invasive knee replacement systems and our wide range of related products and services make us valuable partners to health-care providers in more than 80 countries.

Zimmer Durom Cup Recall

The company voluntarily recalled the product in July of 2008, and the recall details include;

• Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement)
• The recall affected all units, was nationwide and totalled 19,014 cups.
• Recall numbers include # Z-2415-2008, # Z-2416-2008, # Z-2417-2008, # Z-2418-2008, # Z-2419-2008, # Z-2420-2008, # Z-2421-2008, # Z-2422-2008, # Z-2423-2008, # Z-2424-2008, # Z-2425-2008, # Z-2426-2008.

Orthopedic Surgeon Lawrence Dorr

On April 22, 2008, Dr. Lawrence Dorr, a renowned orthopedic surgeon decided it was time to inform his colleagues of his results the previous two years with the Zimmer Durom Cup, after he found that 14 of the 165 patients he treated had to undergo revision surgery within two years of the initial implantation. The letter Dr. Dorr wrote to his colleagues is included below.

April 22, 2008
To: All AAHKS Members
From: Larry Dorr, MD

This NOTICE is to inform you that we have had ten revisions in 165 hips and have four more that need to be revised using the Durom cup (Zimmer, Inc). This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines.

We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions. We have notified Zimmer. The FDA has been notified and we will notify them of our continued revisions.

The company does not believe it should pull the cup from the market so I am notifying all of my colleagues of our failure rate with this cup. I went through a similar scenario with the Sulzer cup failures where I was the only one experiencing revisions at the beginning and basically it was assumed that it was our technique. I can assure you that this goes beyond technique.

I learned my lesson in not informing everyone about this magnitude of failures with the Sulzer cup problem, so it is my obligation to do so with this cup. If you have any questions, do not hesitate to contact me.

Sincerely,
Larry Dorr, MD