Metal-on-Metal Hip Implants - Consumer Justice Foundation

Metal-on-Metal Hip Implants

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Patients who receive metal-on-metal hip implants may be at risk for severe side effects like device fracture, loosening of the implant, metal blood poisoning, or the need for revision surgery.

Patients suffering from deterioration of the hip joint are sometimes advised by their physicians to replace the injured hip with an artificial hip implant, and among the various models and designs of artificial hips, metal-on-metal implants have been some of the most widely-used. Patients who opt for this method of treatment typically do so under the impression that the implant will repair the injury or relieve their pain without causing them any unnecessary harm. Unfortunately, the mounting number of defective hip implants on the market today has raised serious concerns about the safety of these medical devices and the adverse side effects defective hip implants may impose upon patients. As the makers of artificial hip implants continue to issue recalls for their devices, the public is finally being made aware of the adverse events recipients of defective hip implants may be exposed to. If you received a metal-on-metal hip implant and have since suffered from a serious side effect like implant loosening or device fracture, contact an experienced attorney today for legal help.

Metal-on-Metal Alternatives for Hip Implants

While all artificial hip implants carry a potential risk of complications, the FDA has warned that metal-on-metal devices have unique risks in addition to the general risks of all hip implants. In light of the potential for metal-on-metal hip implants to put patients at unnecessary risk for devastating complications, many patients are researching alternative hip replacement systems that may be safer and equally as effective, including the following artificial hip devices:

  • Metal-on-polyethylene implants
  • Ceramic-on-polyethylene implants
  • Ceramic-on-ceramic implants
  • Ceramic-on-metal implants

Other more conservative options for treating deterioration of the hip joint that don’t involve surgery to replace the hip may include pain medication and physical therapy. In light of the potential for metal-on-metal hips to cause serious side effects in patients, the FDA recommends that orthopaedic surgeons choose a metal-on-metal hip implant only after determining that the benefits and risks of using an all-metal device outweigh the benefits of using an alternative hip system.

What are Metal-on-Metal Hip Implants?

Artificial hip replacement systems with ball and socket components that are made from metal, more specifically cobalt and chromium.

Artificial hip implants date back several centuries, and are commonly implanted in patients who have suffered arthritis in the hip joint, a fracture or similar injury to the hip, or a deterioration of the hip joint over time. According to the FDA, “Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacements or hip resurfacing.” The main goal of artificial hip replacement systems is to reduce pain and increase mobility, and, while there are a number of different hip implant designs and models sold by various manufacturing companies, the three basic components of a hip implant include: a cup that attaches to the pelvis, a ball that attaches to the top of the femur, and a stem that is inserted into the femur.

Today’s artificial hip are made from a combination of materials, including metal, ceramic and plastic, but some of the most widely-used devices are metal-on-metal hip implants with ball and socket components made from chromium and cobalt. The three types of hip replacement procedures that use metal-on-metal implants include total hip replacement, hip resurfacing and partial hip replacement. Patients who received metal-on-metal hip implants in the past were led to believe that the devices would reduce their pain and increase their mobility, but many of these implant recipients have experienced devastating complications allegedly caused by the metal-on-metal devices, including device fracture, implant loosening and a type of metal blood poisoning called metallosis, caused by debris from the metal components rubbing together during normal wear and tear being released into the bloodstream.

What is a DePuy Hip Implant?

DePuy hip implants are metal-on-metal hip replacement systems designed to increase range of motion and enhance stability, allowing users in need of a hip implant to return to normal, active lives following surgery. In general, the metal-on-metal design of DePuy artificial hips was supposed to help with failure rates, but studies have shown that the all-metal construction of these implants is inherently flawed and may actually put users at risk for other, more serious problems.

DePuy Total Hip Replacement System

The DePuy total hip replacement system has been implanted in approximately 93,000 people worldwide. In this surgery, the ball at the femoral head and the socket in the pelvic bone are replaced with an artificial ball and socket. The femoral head is cut off in order to accept the stem portion of the device. Recent research has shown that thirteen percent of people who have received the implant required revision surgery within five years of the original surgery.

DePuy Hip Resurfacing Implant

The DePuy resurfacing implant was developed as an alternative to a total hip replacement and is generally a more preferred method. The resurfacing method requires only a partial replacement which places a metal cap on the femur, and because less bone is removed from the patient’s body in this process, the risk of dislocation is lower. Also, since this method allows a larger portion of the bone to be preserved, revision surgeries, if necessary, are less complicated. However, data shows that one in eight, or twelve percent, of people who receive the resurfacing implant required revision surgery within five years of implantation due to hip implant failure.

What is a Pinnacle Metal-on-Metal Hip Implant?

Metal-on-metal Pinnacle hip implants are artificial hips introduced by Johnson & Johnson’s DePuy Orthopaedics unit in 2000, and the metal liner portion of the Pinnacle hip was eventually removed from the market in 2013, amid complaints that the devices were prone to early failure, resulting in injuries like unexplained hip pain, metal blood poisoning, implant fracture and device loosening. Like the ASR hip implant also developed by DePuy Orthopaedics, the Pinnacle hip system can be used with metal-on-metal components, which can wear significantly even with normal use, resulting in tiny microscopic metal particles being released into the patient’s body. According to reports, the metal-on-metal design of the Pinnacle hip implant causes friction between the cup and the ball-shaped component that attaches to the thigh bone, which can cause the device to prematurely erode and release metal ions that can lead to serious side effects in patients.

The Pinnacle hip was marketed by DePuy as a good option for younger, more active patients, and the more durable the material used in the device (i.e. the metal-on-metal design), the more they could supposedly withstand the lifestyles of younger patients without failing prematurely. Unfortunately, this does not appear to be the case, and many patients who received a Pinnacle metal-on-metal hip have suffered devastating complications. As it turns out, the design of the Pinnacle hip implant was based on a nearly identical DePuy product already on the market – the Ultima Metal-on-Metal Acetabular Cup. According to a study conducted by doctors from the UK, regarding the failure rate of the Ultima hip in 2010, of the 545 patients who received an Ultima hip, 90 devices (13.8%) in 82 patients were revised after they failed prematurely. During revision surgery, the doctors found serious problems, like ruptured tendons, cloudy fluid pockets in the hip, and severe tissue death.

What is a Stryker Hip Implant?

Stryker’s Rejuvenate, ABG II and Accolade modular-neck hip stems are artificial hip implants made from Stryker’s proprietary titanium alloy called TMZF (titanium, molybdenum, zirconium and iron), and the stem of Stryker’s hip implants have a PureFix HA coating, which is designed to help stimulate bone growth around the implant, for an overall better fit. Unlike typical hip replacement systems, the Stryker implants also feature several interchangeable neck and stem components, which are designed to be custom-tailored to patients for a more anatomically-correct fit. Stryker claimed that its patented TMZF blend made the company’s hip implants resistant to corrosion and fretting – occurring when small metal particles flake off the device and into the body – and “more closely resembles that of bone.” However, post-market data of Stryker hip implants revealed that the devices were indeed prone to fretting and corrosion, and put patients at risk for implant loosening, metal blood poisoning and other complications.

Stryker Rejuvenate Modular-Neck Stem

Stryker’s Rejuvenate hip implant system features six stems and 16 necks, and was marketed as a longer-lasting device that offered a better range of motion for younger, more active patients. Because the Rejuvenate implant uses a ceramic component, it was intended as an alternative to metal-on-metal implants.

Stryker ABG II Modular-Neck Stem

Stryker’s ABG II hip system features eight left stems, eight right stems and ten modular necks, and the implant was designed to provide patients with a highly customizable hip replacement that offered superior stability, an even load transfer, and healthy bone remodeling, without the risk of corrosion or fretting.

Stryker Accolade Femoral Stem

Stryker’s Accolade hip implant is a metal femoral stem made from one single, solid piece of titanium alloy designed to be used with a metal acetabular cup for a complete metal-on-metal hip implant. The Accolade implant features a tapered wedge designed to help the device fit more patients and accommodate a greater number of surgical approaches.

Side Effects Possibly Resulting in Defective Hip Implant Lawsuits

Thousands of hip implants have been recalled in recent years because of high failure rates. While many patients have already experienced one or more adverse side effects of a defective hip implant, thousands more have been implanted with the potentially dangerous devices and still don’t know it. Some of the most serious injuries that have been reported by defective hip implant recipients include dislocation of the implant, hip fractures, infection, bone death, metal blood poisoning and loosening of the implant. In most cases, these side effects require a second surgery, called a revision surgery, in order to repair the problem or to replace the implant completely. Unfortunately, some defective hip implant complications may be even more serious than the injury that warranted the use of an artificial hip in the first place.

  • Metallosis (metal blood poisoning)
  • Infection
  • Immobility
  • Implant dislocation
  • Bone fracture near the implant site
  • Loosening of the implant within the body
  • Nerve and bone damage
  • Pain and swelling
  • Soft tissue growths

Although Stryker modular-neck hip stem systems are not technically considered metal-on-metal implants, because there isn’t a metal ball rubbing against a metal socket during use, the devices are made of chromium and cobalt, and the stems are coated with titanium, which means Stryker hips do have a metal-on-metal junction that can cause similar complications to metal-on-metal hip implants.

Link Between Artificial Hips and Complications

Metal-on-metal hip implants have been marketed by their manufacturing companies as durable alternatives to other artificial hips, experiencing less wear, accepting larger bearings than other implants, and withstanding the active lifestyle of younger patients. However, research has shown that all-metal implants may have design flaws that make them susceptible to early failure rates and other complications, and these problems have led many manufacturing companies to recall their metal-on-metal hips. Some of the most popular hip implants that have been plagued with problems in recent years include the following:

  • DePuy ASR Hip Resurfacing System
  • DePuy ASR XL Acetabular System
  • DePuy Pinnacle hip replacement
  • Stryker Rejuvenate modular-neck hip stem
  • Stryker ABG II modular-neck hip stem
  • Stryker Accolade femoral stem
  • Zimmer Durom Cup
  • Smith & Nephew modular R3 Acetabular System
  • Biomet M2a Magnum modular hip implant
  • Wright Medical Conserve Plus Total Resurfacing Hip System
  • Wright Medical Profemur Z Hip Stem

Although there have been several recalls issued for defective hip implants by the device manufacturing companies, hip implants that haven’t yet been recalled may also fail and cause serious injury to patients.

Over the past several years, the FDA has received hundreds of complaints from patients who received metal-on-metal hip implants and subsequently suffered serious injuries, like metal blood poisoning, bone fractures and early implant failure. Unlike new drugs that must undergo extensive testing before they are approved for sale in the United States, some hip implants can receive FDA approval if they resemble an implant already in use. This allows untested products to enter the market and be used in implant surgeries, potentially causing serious problems and the need for a recipient to receive an extremely complicated and costly implant replacement surgery. As a result of injuries from defective hip implants, the manufacturing companies face product liability lawsuits brought on behalf of consumers whose artificial hips failed prematurely and had to be removed or replaced.

According to the FDA, “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant joint.” This damage caused by metal debris from all-metal hip implants is sometimes referred to as an adverse local tissue reaction (ALTR) or an adverse reaction to metal debris (ARMD). In its 2013 safety communication, the FDA warns that soft tissue damage from metal-on-metal hip implants may lead to severe complications like chronic pain, device failure, implant loosening and the need for revision surgery.

Lawsuits Against Hip Implants for Loosening, Implant Fracture, Metallosis and Other Injuries

June 2010 – The first defective hip implant lawsuit in the United States is filed against DePuy.
December 2010 – The Judicial Panel on Multidistrict Litigation transfers all DePuy hip implant lawsuits filed in courts across the country to the Northern District of Ohio for consolidated pretrial proceedings as part of a multidistrict litigation (MDL).
2011 – A resident of Nashville, Tennessee files a defective hip implant lawsuit against DePuy Orthopaedics, after requiring revision surgery to remove her faulty ASR implant, which caused her “debilitating pain and weakness,” among other injuries.
March 2011 – A woman from Tennessee files a lawsuit against DePuy after undergoing revision surgery to remove her defective hip implant, which caused her “debilitating pain and weakness, significant inhibitions of her ability to walk and move, elevated blood levels of chromium and cobalt,” and other injuries.
March 2011 – DePuy faces a product liability lawsuit brought on behalf of a Tennessee man who required revision surgery when his DePuy Pinnacle metal-on-metal hip implant failed.
September 2011 – An Australia class action lawsuit is filed against DePuy and J&J, alleging that the ASR hip replacement system was defectively designed and that DePuy knew there were problems with the artificial hip but failed to provide adequate warnings about this risk.
January 2012 – A Tennessee man files a complaint against DePuy and Johnson & Johnson, seeking compensation for injuries he suffered after his DePuy hip implant failed.
August 2012 – The first defective hip implant lawsuit against Stryker is filed in New Jersey court.
August 2012 – Three women who required revision surgery because of their defective hip implants file DePuy ASR hip implant lawsuits in Las Vegas, and J&J settles the cases for $200,000 per claim.
October 2012 – A federal judge consolidates Biomet M2A Magnum hip implant lawsuits into a multidistrict litigation in the U.S. District Court for the Northern District of Indiana.
December 2012 – A South Carolina man files a hip implant lawsuit against Biomet, alleging that the company’s M2A Magnum device is defective.
January 2013 – Evidence presented at the first DePuy ASR hip implant trial indicates that the manufacturer knew at the time of the ASR recall that the metal-on-metal device was expected to fail within five years in 40% of patients.
January 2013 – Expert witnesses testifying in court indicate that the ASR hip implant failed DePuy’s own safety tests because the device released 16 times more chromium and cobalt debris during use than the Pinnacle hip implant.
January 2013 – Johnson & Johnson and its DePuy subsidiary knew in 2008 that there were problems with the ASR hip implant, but waited two years to issue a recall, according to expert testimony and documents unsealed in California state court.
March 2013 – In one of the first DePuy ASR hip implant lawsuits to go to trial, a Los Angeles jury rules against DePuy Orthopaedics, finding that the artificial hip was defective in design, and awards the plaintiff $8.3 million in damages.
April 2013 – A Chicago jury returns a verdict in favor of DePuy in a lawsuit filed by a 54-year-old nurse who suffered painful tissue damage requiring revision surgery just three years after receiving her ASR hip implant.
May 2013 – Following a five-week trial in California state court, a Los Angeles jury finds that the ASR hip implant is defective in design and awards the plaintiff $8.3 million in damages for his injuries.
November 2013 – Johnson & Johnson agrees to settle 7,500 ASR hip implant lawsuits brought against its DePuy subsidiary, for $4.4 billion, or about $250,000 per claim.
February 2014 – Biomet agrees to pay $56 million to resolve more than 1,000 Magnum M2A hip implant complaints, which works out to about $200,000 per claim.
March 2014 – About 8,000 plaintiffs pursing legal action against DePuy for its recalled ASR hip implants must decide by April 1 whether to opt-in or opt-out of a multi-state settlement worth roughly $4 billion.
October 2014 – A Texas jury rules in favor of DePuy in a product liability lawsuit filed by a woman who claims that she was poisoned by a DePuy Pinnacle hip implant and required multiple revision surgeries to replace the implant and address her tissue infections, metal blood poisoning and other injuries.
November 2014 – J&J proposes resolving more than 1,000 product liability lawsuits involving the recalled DePuy ASR implant for $250 million.
February 2015 – A woman who required surgery to replace two faulty ASR hip implants is awarded $2.5 million in damages by a jury in Oklahoma.
February 2015 – Johnson & Johnson agrees to pay about $420 million more to resolve an additional 1,400 lawsuits filed on behalf of individuals who received an ASR hip implant and required revision surgery between August 31, 2013 and January 31, 2015.
February 2015 – An Oklahoma jury returns a verdict in favor of the plaintiff in a lawsuit brought against DePuy over injuries and revision surgeries associated with the company’s ASR XL metal-on-metal hip implants.
March 2016 – A Texas jury rules against Johnson & Johnson in the second bellwether trial involving injuries from the company’s Pinnacle artificial hip, awarding a whopping $498 million in compensatory and punitive damages to five plaintiffs in the consolidated case.

FDA, Hip Implants and Side Effects

July 2008 – Zimmer briefly recalls the Durom Cup hip implant to revise the device instructions, but the artificial hip returns to the market.

December 2009 – DePuy withdraws the ASR hip implant from the Australian market, and details a plan to phase the device out worldwide by 2010, citing slow sales as the reason for its removal.

March 2010 – DePuy finally acknowledges in a letter to doctors that its ASR metal-on-metal hip replacement system is defective and prone to early failure. At this time, the FDA has already received hundreds of reports of early failure involving the ASR hip implant system.

August 2010 – The FDA recalls two metal-on-metal hip implants manufactured by DePuy Orthopaedics, the ASR XL Acetabular System and the ASR Hip Resurfacing System.

2011 – Johnson & Johnson estimates in an internal document that the ASR hip implant would fail within five years in 40% of patients who received the artificial hip.

February 2011 – Federal regulators launch an all-metal hip implant webpage to provide updated safety information and recommendations to consumers and medical professionals.

May 2011 – The FDA requires the manufacturers of metal-on-metal hip implants to conduct post-market surveillance studies on the safety and effectiveness of their artificial hips.

April 2012 – Stryker issues an Urgent Field Safety Notice to surgeons involving problems with the its Rejuvenate and ABG II implants, including “Excessive metal debris and/or ion generation” caused by “fretting and or/corrosion at or about the modular neck junction.”

June 2012 – Smith & Nephew recalls the metal liner components of its R3 Acetabular System, after thousands of patients in the U.S. received the implant from 2009 and 2012.

June 2012 – The Orthopaedic and Rehabilitation Devices Advisory Panel meets to discuss the safety and effectiveness of metal-on-metal hip implants, and finds that there is little reason for surgeons to continue using the controversial devices.

July 2012 – Stryker recalls two hip replacement systems – the ABG II and Rejuvenate modular-neck hip stems – both of which had been linked to complications like metallosis, tissue death and hip implant loosening.

September 2012 – Artificial hip manufacturer, Smith & Nephew, issues an “Urgent Field Safety Notice,” warning the public that the Birmingham hip device is tied to a higher rate of failure than is acceptable in the UK.

September 2012 – Health regulators in Australia recommend routine blood tests and soft tissue imaging for all patients implanted with a metal-on-metal hip implant.

January 2013 – The FDA issues a safety communication to provide updated information to patients and medical professionals about the safety and effectiveness of metal-on-metal hip implants.

January 2013 – The FDA issues a proposed order requiring the makers of all-metal hip implants to submit premarket approval applications.

May 2013 – DePuy removes its Ultamet and Complete all-metal hip implant liners from the market, and announces that it is phasing out its metal-on-metal products in favor of plastic and ceramic devices.

November 2013 – Hospitals in the UK ban metal-on-metal hip implant systems, due to higher-than-expected failure rates.

Artificial Hip Side Effect Studies

November 2010 – Researchers from the UK publish a study on the failure rate of the Ultima metal liner, designed to be used with DePuy’s Ultima Metal-on-Metal Acetabular Cup, and found that 13.8% of hips required revision surgery after failing. During the revision surgeries, doctors found a number of serious complications, including cloudy fluid pockets in the hip, ruptured tendons and necrosis (tissue death).

October 2011 – In a special report published in the Archives of Internal Medicine, researchers examined a Department of Justice settlement agreement with five major hip implant manufacturers – DePuy, Biomet, Smith & Nephew, Stryker and Zimmer – and found that orthopedic surgeons received payments from these five companies for consulting, research and clinical study work, as well as royalties on products they helped develop.

February 2012 – The BBC and the British Medical Journal launch an investigation into all-metal hip implant concerns, and report that there may be hundreds of thousands of patients who have faulty hip replacement systems that may expose them to toxic metal.

March 2012 – Metal-on-metal hip implants are significantly more likely to fail than other models of artificial hips, according to research published in The Lancet.

March 2012 – A study conducted by the National Joint Registry of England and Wales finds that 12% of patients who received the DePuy ASR resurfacing implant, and 13% of those who received the ASR total hip replacement, required revision surgery after five years, to remove or replace the faulty device.

June 2012 – The Journal of Bone and Joint Surgery publishes a study indicating that patients who receive all-metal total hip replacements may be ten times more likely to develop pseudotumors, or semi-solid masses that are greater than two centimeters in diameter.

December 2012 – The medical journal Orthopedics publishes a study highlighting the case of a 54-year-old woman who received the DePuy Pinnacle implant and developed soft-tissue growths called bursal cysts in her hip, due to metal debris shed by the implant. The cysts reportedly cut off circulation to her lower leg and she underwent revision surgery to replace the device with a ceramic-on-ceramic implant.

February 2013 – Research published in the Journal of the American Medical Association finds that women are 29% more likely than men to require revision surgery for artificial hip implant failure within three years.

Why We Think the Makers of Hip Implants Should be Held Liable for Side Effects

Many recipients of metal-on-metal hip implants have pursued corrective actions to repair or replace their damaged hip devices, including revision surgery, which can take both a physical and financial toll on patients. Many of these same patients have taken legal action against the makers of metal-on-metal hip implants, accusing the manufacturing companies of:

  • Manufacturing and selling defective devices
  • Failing to research the long-term effects of their products
  • Knowing that their hip replacement systems were defective
  • Failing to provide adequate warnings to consumers and the medical community about the risk of complications from all-metal hip implants
  • Knowing that their all-metal hips carried a higher-than-expected rate of failure within just a few years after being implanted
  • Willfully concealing problems with metal-on-metal hip implants from the general public

What should you do? If you believe you have been harmed by side effects of an artificial hip implant, you should contact an attorney as soon as possible to discuss filing a lawsuit against the device manufacturing company.

Receiving a defective hip implant can significantly affect the rest of your life, potentially resulting in debilitating injury to the bone or joint, restricted movement, and even damage to internal organs and the nervous system. If you or a loved one has suffered from adverse side effects allegedly associated with a metal-on-metal hip implant like DePuy’s ASR hip replacement system, contact a reputable product liability lawyer today. You may be entitled to financial compensation for your injuries, medical bills, lost wages, and pain and suffering, which you can collect by filing a defective hip implant lawsuit against the manufacturing company. You are not at fault for any injuries caused by a defective product, especially medical devices like hip implants that are designed to correct injuries, not cause them. With the help of a qualified defective product attorney, you can collect the compensation you deserve and protect yourself from further harm.

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