Articles Posted in Hip Implant Failure

As we age, it is normal that our bodies begin to deteriorate.  Common areas prone to deterioration are the joints, i.e. knees, hips, etc.  Wear and tear on these parts of the body can cause pain, stiffness, and difficulty walking.   Physicians typically prescribe conservative treatment such as physical therapy, exercise and medications, but often times, joint deterioration requires total replacement or resurfacing.  Hip replacements are one of the most common joint replacements.

There are several types of hip implants used in replacement surgery, five currently being available in the United States.  These are, Metal-on-Polyethylene, Ceramic-on-Polyethylene, Metal-on-Metal, Ceramic-on-Ceramic, and Ceramic-on-Metal.  All of these implants have different risks and benefits.  The same implant can also react differently depending on the patient.  The different types of implants refer to the different materials used to make the ball and sockets of the artificial hip.  In metal-on-metal hip implants, both the ball and the socket of the device are made from metal.  Some notable advantages of metal-on-metal hip implants are “bone conservation on the femoral side with possible lower dislocation rates”, better range-of-motion, more normal walking posture, increased activity, and “increased ease of insertion with proximal femoral deformities or retained hardware, and straightforward revision”.

However, there are many risks with these replacement surgeries.  Common adverse effects regardless of the type of implant are hip dislocation, bone fracture, joint infection, local nerve damage, device loosening or breakage, difference in leg lengths, and bone loss.  Even with these potential complications, data from an FDA study performed of patients from Australia and the U.K. shows that 95 percent of patients with any type of total hip replacement have not undergone revision surgery for at least seven years after their initial operation.  Specifically with metal-on-metal implants, over 85 percent of patients have not have a revision for at least seven years after the initial implant.  Interestingly, patients with larger heads, defined as 36mm or larger, had more revisions than those with smaller heads.

Although this is true for this study, there has recently been a massive recall for several different manufacturers of hip implants in the U.S.  Consumer’s Union found that from 2002 to 2013 hip implant recalls six major manufacturers, Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer.  However, these recalls came after the implants had already been used in hundreds of thousands of hip replacement surgeries.  In total, more than 500,000 patients in the United States received metal-on-metal hip implants after they were claimed to be more durable and provide a greater range of motion when compared to older forms of artificial implants.  However, it was later found that the manufacturers’ claims that the implants were more durable were false.  These metal hip replacements began failing rather quickly.  Common symptoms of hip replacement failure are regular and prolonged pain around the groin, hip, or leg, swelling near the hip joint, and difficulty walking.  The key reason these metal-on-metal hip replacements are failing is due to the friction caused by the normal movement of the device.  This friction releases microscopic shavings and metal debris into the tissue around the joint.  Consequently, this can cause metallosis, a build up of metal fragments in the soft tissues of the body, which causes painful and inflamed joints and a high blood-metal count.  Continue reading

Stryker, a company that makes artificial hip implants, has reached a settlement to resolve thousands of products liability lawsuits over the now-recalled medical devices. The deal is expected to cost the manufacturer approximately $1.43 billion.

The agreement covers patients who were implanted with the ABG II Modular-Neck or the Rejuvenate Modular-Neck and had to undergo another procedure to have the hip implant replaced. Both models were recalled in 2012 in the wake of growing patient complaints of corrosion and other problems.

According to the plaintiffs, Stryker sold the faulty implants, which deteriorated in their bodies and caused them illness, swelling, and pain. Their defective medical device lawsuits accused Stryker of negligence for failing to properly test the ABG II and Rejuvenate models before releasing them and not warning doctors and patients about the possible side effects and risks. Some of the devices loosened while in patients, while others released toxic metal into the bloodstream.

With a Monday, January 6, 2014 deadline looming for people looking to avail of a multibillion-dollar DePuy ASR settlement deadline, many of those who were forced to undergo revision surgery to replace their faulty hip implants are rushing to meet the deadline to register their claim. That said, there will be another filing date so even if you aren’t ready just yet, you should still speak with an experienced Boston hip implant defect law firm to find out whether you have grounds for a Massachusetts products liability case.

To qualify for this settlement, your revision surgery would need to have taken place by August 31, 2013. Each plaintiff is to get $250,000 plus additional compensation depending on what other costs and damages they incurred. (Reductions, however, will also be factored in if a patient had his/her device for longer than five years.)

According to The New York Times, Johnson & Johnson, of which DePuy is a subsidiary, has put aside over $2.5 billion for these hip implant cases alone. Some 8,000 patients in the US who had to have their all-metal artificial hip implants taken out and replaced are expected to qualify for this deal. That said, there are still thousands of other patients who were also impacted by these faulty Articular Surface Replacement devices and do not qualify.

When implanted medical devices cause injuries to a patient, are improperly labeled or defectively manufactured, or otherwise fail after being implanted, a device manufacturer or the Federal Drug Administration will initiate a recall. Too often though, these recalls come after there have been hundreds of complaints filed by injured patients.

medical-doctor-1314902-m.jpgMost recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.

What Are ShapeMatch Cutting Guides?

ShapeMatch Cutting Guides are single-use, disposable cutting guides that are intended to be used as surgical instrumentation to assist surgeons in positioning the Stryker Triathlon Knee System. This software is used to guide where surgeons will cut and shape a patient’s bone before implanting the replacement knee device.

About the Recall

In April of 2013, Stryker Orthopedics issued a Level 1 voluntary recall of the Shape Match Cutting Guides, after becoming aware of the potential issues with the software. It was found that the software did not meet surgeon’s pre-operative planning parameters, and some manual edits used in the software did not meet the standards of the FDA. The overall effects these discrepancies in the software resulted in improper cutting of bones, as well as many serious adverse health consequences for patients who had Stryker system knee replacements including poorly-fitting, loose knee implants, knee fractures, chronic pain, and the need for revision surgery.

Your Consumer Rights

Like all knee replacement device manufacturers, Stryker has a legal obligation to properly design, test, and ensure their products are working correctly. They also are responsible for warning the public of any problems with their products, no matter how minor.
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Lisa Lincoln has filed the first federal Stryker ABGII hip lawsuit in the U.S. District Court for the District of Massachusetts. Her complaint comes nearly one year after Stryker recalled its Rejuvenate Modular and ABG II hip implant parts because of possible risks, such as corrosion/fretting of/around the modular-neck stems.

In her hip injury lawsuit, Lincoln claims that her ABG II system implant caused her to develop a number of health issues, including metallosis, and she has been forced to undergo revision surgery. (High cobalt levels in her blood indicate that this condition was caused by the stem and metal neck rubbing together.) She also said that not even two years after she was implanted with the hip replacement parts, she was already experiencing chronic pain and developed a pseudo-tumor on the back of the acetubular cup.

Meantime, her doctors reportedly found fluid accumulation around her hip implant, which are signs of early failure and loosening. Lincoln is suing for products liability, alleging negligence and breach of express and implied warranties. Her husband is seeking damages for loss of consortium.

A California jury ruled on March 8, 2013 that DePuy Orthopaedics knowingly produced and marketed a defective hip replacement device known as the DePuy ASR™ Hip Resurfacing System. The basis of the verdict was that DePuy (a subsidiary of Johnson & Johnson) failed to warn consumers of the dangerous effects that the metal device may have on the body.

During the trial, experts stated that the grinding of the metal apparatus caused dangerous metal toxins to be released into the bodies of patients who were implanted with the device, and caused various medical complications including dislocation, infection, and the need for a second replacement surgery. The jury spoke explicitly of Johnson & Johnson’s responsibility.
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Loren Kransky was awarded $8.3 million in a court settlement with Johnson & Johnson and its subsidiary DePuy Orthopaedics, Inc. for injuries, expenses, and damages he encountered relative to the DePuy ASR™ XL metal-on-metal hip replacement he received in 2007. This is the first of over 10,000 lawsuits that have been filed against Johnson & Johnson and DePuy since the ASR™ Hip Resurfacing System and the ASR™ XL Acetabular System were recalled in 2010. An estimated 93,000 patients worldwide were implanted with the ASR System.

The ASR Hip System was developed by orthopaedic surgeons and biomedical technicians for a procedure called resurfacing which is used by surgeons seeking an alternative method to the standard hip replacement for patients with severe arthritis and disease of the hip joint.

The major issue of the ASR Hip System as well as other hip replacement devices is its metal cup and ball components. Doctors and researchers have asserted that the design is flawed and has a high wear rate which causes complications such as dislocations, severe pain, infection, and often the need for a second revision surgery. Patients who have received the implant have also reported, which occurs when metal debris enters the bloodstream.
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At Altman & Altman, LLP, our hip implant defect lawyers represent clients throughout the US that have been injured because of faulty or dangerous medical devices. One of these devices, the Stryker Rejuvenate hip replacement system, is causing many patients post-implant complications.

Unlike many of the other hip replacement devices that have been associated with serious side effects, the Stryker Rejuvenate isn’t a metal-on-metal device. It does, however, have parts that are metal-on-metal and has been linked to a greater risk of metallosis.

Metallosis is a medical condition that causes metal debris to build up in the body’s soft tissue. It can lead to pain, hip joint failure, mobility limitations, bone dissolution, pseudo-tumors, chromosomal aberrations, and bone dissolution. The Stryker Rejuvenate hip replacement system is also associated with an early failure rate that is unusually high, meaning that some patients are having to get their implants replaced way earlier than is acceptable (within five years rather than in 15 to 20 years), which is forcing them to undergo revision (replacement) surgery. As a result, they are once more exposed to the risks that are involved with this type of surgical implant procedure. They also must then undergo rehabilitation and learn how to function with their replacement implant.

The first defective medical device lawsuit over a DePuy hip implant has gone to trial. The plaintiff, Loren Kransky, is seeking damages for injuries he says he sustained from the faulty replacement system.

The retired prison guard contends that debris from the implant’s metal parts caused metal ions to enter his bloodstream. He says his doctor told him he had to undergo hip replacement surgery or risk poisoning.

Kransky is one of thousands of plaintiffs suing Johnson & Johnson, which owns DePuy Orthopedics, over the faulty hip replacement systems that have been linked with an excessively high rate of failure. The medical device makers recalled the devices belonging to the ASR systems in 2010.

Marcia and Peter Scherone have filed a hip implant defect lawsuit against Zimmer Holdings Inc. They contend that Marcia sustained femur fractures because she had been fitted with a Zimmer hip implant that was defective, As a result, they claim, she had to undergo over six revision surgeries to fix the damage sustained to her leg and hip. The Scherones are suing for negligence, breach of express and implied warranty, loss of consortium, and strict liability.

Marcia, who was implanted with the Zimmer Trilogy hip device in 2005, suffered a fracture while in the shower in 2008 and dislocated her hip. She blames her injuries on the faulty hip implant device, which had to be removed after its plastic liner split in two.

In the last couple of years, Marcia has been forced to use a walker and wheelchair and continues to experience pain from her injuries. She also has not been able to function normally in her professional and daily lives. The plaintiffs want damages for Marcia’s past and ongoing pain and suffering.

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