Several different types of metal-on-metal hip implants have been recalled and have come under fire in recent medical research. In July 2012, for instance, Stryker Orthopaedics announced the recall of its Rejuvenate Modular and ABG II modular-neck hip stem implant devices.
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The U.S. Food and Drug Administration (FDA) has warned of premature failure of all-metal hips, which consist of a ball, stem and shell made from cobalt-chromium-molybdenum alloys.
When the moving parts of the artificial hip’s metal ball-and-socket joint rub together, metal fibers may flake off, according to the FDA. This can damage and destroy tissue surrounding the joint. It may also cause metal ions to enter the bloodstream and cause additional illness. Due to these side effects, all-metal hip implant patients may need extensive medical treatment, including surgery to remove the defective device.
If you believe that you or a loved one has been injured by a metal-on-metal artificial hip, Salvi, Schostok & Pritchard P.C., can help you. Call us today toll free or contact us online. We can provide a free, no-obligation consultation.
You must file your case within the applicable Statute of Limitations (“SOL”), which varies from state to state, and is also based on the type of lawsuit. In Illinois, the SOL for a products liability case is two years from the date when you knew, or should have known, that the problems you were experiencing were caused by the product. One of our attorneys can evaluate what the applicable SOL date is for your case.
There are 3 types of hip replacement surgeries: total hip replacement where (4 parts) the ball, shell, liner and stem going into the femur bone are replaced; partial hip replacement where the ball is replaced, and hip resurfacing in which only the cup is replaced. Any one of these could cause symptoms and failure due to metal components rubbing against other parts of the hip.
Serum cobalt and chromium are recommended tests for evaluation of joint implant failure. Elevated cobalt and chromium levels may indicate that the implant is faulty and a revision surgery may be required. Implant failure is likely when chromium levels exceed 15 ng/mL and cobalt levels exceed 10 ng/mL, as these levels indicate significant implant corrosion.
A pseudotumor is a tumor-like mass representing an inflammatory reaction. When a metal on metal artificial hip deteriorates, cobalt and/or chromium particles will flake off into the body. As a result, the body will react by becoming inflamed, creating tissue masses or fluid, or the tissue could die and become necrotic.
Zimmer’s high-flex NexGen knee implants were supposed to allow a greater degree of flexibility. Unfortunately, these implants have resulted in an extremely high failure rate, which is suspected to be a result of the implant’s defective design. If you or a family member have been implanted with a Zimmer NexGen Knee Implant and you are experiencing any pain or loosening, you should first consult with your doctor or orthopedic surgeon to determine whether you require medical attention.
The proper jurisdiction to file your case is based on a number of factors, including where you received most of your treatment or where you reside. Currently, lawsuits for Zimmer NexGen knee implants are being handled individually, on a case-by-case basis. Cases filed in federal court have been consolidated in Multidistrict Litigation (“MDL”) in the US District Court for the Northern District of Illinois (Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272). Filing in the MDL helps to expedite discovery and promotes judicial efficiency, while also allowing each case to proceed individually.
The FDA first indicated concern about metal-on-metal hip implants in May 2011. The agency asked manufacturers to conduct post market surveillance studies of the devices. The FDA wanted to learn more about metal ion concentrations in the bloodstream of implant recipients.
Prior to FDA action, data had emerged among international orthopedic implant registries and various professional/scientific organizations. The data indicated serious complications and potential problems arising from the early failure of metal-on-metal (MoM) hip systems.
In April 2010, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) recommended blood tests and imaging for patients who had received all-metal hip implants and were experiencing abnormal pain.
In addition to the U.K. registry’s warning, Health Canada and the Therapeutic Goods Administration of Australia each published alerts in 2012 about MoM hip implants’ shedding metal flakes and/or chromium ions.
Finally, in a January 2013 Safety Communication, the FDA warned that metal can be released from the contact of the metal-on-metal joints in an artificial hip. Tiny metal particles that wear off from the device around the implant may cause damage to bone and/or soft tissue surrounding the implant and joint, the agency said.
This side effect, called metallosis, can cause pain, implant loosening, device failure and the need for surgery to replace the implant, the FDA said. Metal ions that enter the bloodstream can cause damage in other parts of the body as well.
Metal-on-metal hip implants have been found to fail prematurely and cause a condition known as metallosis as they shed flakes of metal into the patient’s body. Government oversight agencies around the world, as well as researchers and medical professionals’ groups, have warned surgeons and patients about the use of all-metal hip implants.
At least four metal-on-metal hip manufacturers have issued voluntary recalls of their products:
Stryker Orthopaedics announced in July 2012 that it was recalling its Rejuvenate Modular and ABG II modular-neck hip stem implant devices. In its recall notice, Stryker said the artificial hip systems pose a risk of fretting (wearing down and flaking of metal parts) and/or corrosion at or about the modular-neck junction.
Stryker also said information about fretting / corrosion problems collected since the devices entered the market might indicate that the frequency of these problems constituted a trend.
Smith & Nephew recalled the metal liner component within its R3 Acetabular System in June 2012 because of a higher-than-expected number of revision surgeries associated with the use of the device in total hip replacements outside the U.S. The company cited data from the Australian and United Kingdom’s implant registries indicating premature device failures.
The Australian Orthopaedic Association’s National Joint Replacement Registry found that 5 percent of the metal liners used in the R3 Acetabular System had to be replaced after about two years. More than 6 percent failed within four years, according to the UK’s National Joint Registry.
A majority of Smith & Nephew’s recalled metal prosthetic hip components were used in stemmed total hip replacement procedures, the company said. The optional metal liner component within the R3 Acetabular System received FDA premarket approval in November 2008 for use with the firm’s BHR Hip resurfacing head. It was first used in Europe and Australia in 2007 and launched globally in 2009.
DePuy Orthopaedics, a subsidiary of Johnson & Johnson Medical Devices and Diagnostics, issued a voluntary recall of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System in August 2010. The recall was based on data from the U.K.’s joint registry indicating that about 13 percent of implant recipients receiving the DePuy ASR total hip system required revision surgery within five years.
The ASR XL Acetabular Hip System first became commercially available in the U.S. in December 2005, DePuy said. The ASR Hip Resurfacing System was not commercially available in the country. Approximately 93,000 patients worldwide received DePuy ASR hip implants, the company said.
The ASR XL Acetabular System was approved for use in the U.S. through the FDA’s 510(k) approval process, which does not require evidence from clinical testing of a medical product.
Zimmer Inc. recalled its Zimmer Durom Acetabular Component (“Durom Cup”) in July 2008, saying its instructions to surgeons were incomplete.
The Durom Cup is a one-piece metal socket device with a plasma coating. The plasma coating was to stimulate the growth of bone tissue, making the prosthetic joint more stable. Too often, though, the implant did not attach to the existing bone as expected. Implants that failed became loose and had to be replaced.
The American Academy of Orthopaedic Surgeons (AAOS) says more than 1 million metal-on-metal prosthetic hips have been implanted worldwide since 1996. Unfortunately, many of these all-metal hip recipients have experienced serious side effects due to the metal components’ wearing away and metal flakes passing into surrounding soft tissue. When metal ions from the flakes pass into the bloodstream, other parts of the body can be damaged.
Flakes of metal that rub off of the moving parts in a metal-on-metal hip implant can cause a reaction called metallosis around the joint. This is deterioration in soft tissue (fibrosis) or death of soft tissue cells (necrosis). As the artificial joint wears away, and damaged tissue breaks down, the implant comes loose. This can lead to pain and mobility problems.
Another problem is that the small bits of worn metal from an all-metal hip implant can emit metal ions that enter the bloodstream and travel throughout the body. This can cause such reactions as:
If you have contacted your doctor because of any of the above symptoms, the doctor might assess soft tissue damage around a metal-on-metal implant by ordering an MRI, CAT scan or ultrasound. Blood work may also be performed to determine if you have a high concentration of metal ions in your bloodstream.
In cases of infection, hip dislocation or loosening or breakage of the implant itself, revision surgery (replacement of the implant) is usually the recommended course of action. Symptoms of local or body-wide reactions to the metal from your hip implant, such as those above, would also likely prompt a recommendation of revision surgery.
If you have had surgery to remove a metal-on-metal hip implant that failed prematurely, regardless of whether you were diagnosed with metallosis or another malady, you may have a legal right to seek compensation for your pain and suffering and your medical expenses.
Patients injured by defective medical devices, such as all-metal hip implants, can typically seek legal relief through product liability lawsuits. The manufacturers of defective medical devices may be liable based on:
Hip implant patients can pursue lawsuits in state or federal court. Because these cases often involve patients and families from around the country, they may be combined into a class-action lawsuit. They also may be consolidated into “multidistrict litigation,” or MDL, cases to speed up pretrial proceedings.
Regardless of how many patients are involved in a lawsuit, your attorney in a defective medical device case must ensure your rights and interests are protected at each step of the case. This requires an attorney experienced in large and complicated product liability claims.
If you have been injured by a faulty metal-on-metal hip implant, you should take action now to protect your rights.
People who have been harmed by metal-on-metal hip implants might consider personal injury lawsuits. If a hip implant patient has died from complications caused by an all-metal hip, surviving family members might pursue a wrongful death lawsuit.
When numerous people claim they have been harmed by a single faulty medical product, the court may combine similar lawsuits to make them easier to deal with. A class-action lawsuit, for example, may be declared if multiple clients have a shared interest in the case. Another procedure is to declare a multidistrict litigation (MDL) to consolidate multiple lawsuits filed in federal court that share one or more common questions of fact.
Class action or MDL lawsuits do not diminish the plaintiff’s claim or the damages they can expect to collect. These procedures simply allow cases to progress more rapidly.
Several lawsuits against metal-on-metal hip implant system manufacturers have been filed already. Those who have been harmed by all-metal implants have several options. They may initiate their own personal injury or wrongful death lawsuit or, in some cases, join existing class action or MDL suits.
Medical products liability cases are complex. Your case should be entrusted to an attorney experienced with successful litigation of personal injury and medical products liability lawsuits.
If you believe that you or a loved one has suffered injury due to an all-metal hip implant, the Chicago metal-on-metal hip implant lawyers of Salvi, Schostok & Pritchard P.C., can help you.
We have earned more than $1 billion in damages for our clients, including in excess of 225 multimillion-dollar verdicts and settlements. Schedule a free consultation about your case. Call us toll free or complete our online form. We’re ready to help you today.
If you believe that you were injured or lost a loved one due to an all-metal hip implant, contact Salvi, Schostok & Pritchard P.C., today. Our firm has obtained more than $950 million for our clients, including more than 209 multimillion-dollar verdicts and settlements. We can go to work on securing relief for you and your family.
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