Hip Implant Lawsuits
The Centers for Disease Control and Prevention (CDC) reported in 2010 that about 310,800 total hip replacements were performed among adults who are 45 years old and older. That was more than double the amount performed in 2000.
The American Academy of Orthopaedic Surgeons (AAOS) later reported that there were 370,770 total hip replacements in 2014. They projected that by 2030, that number would grow by 171 percent to 635,000 procedures.
These surgeries have helped many people reduce arthritic pain and stay active in their lives. On the other hand, thousands of people have suffered from negative outcomes because of defective products.
The experienced hip implant attorneys at Chaffin Luhana understand that patients rely on medical device manufacturers to make responsible decisions when it comes to protecting public health. These attorneys are now reviewing cases in which patients trusted manufacturers of hip implant devices, only to suffer from serious injuries requiring risky and difficult revision surgeries.
What is Hip Replacement Surgery?
In its early stages, arthritis in the hip may be treated with pain relievers, injections, and physical therapy, along with lifestyle changes. Over time, however, as the damage intensifies and the hip joint degenerates, these treatments may no longer be effective.
Patients who are suffering from chronic hip pain and who can no longer go about their daily activities are often advised to consider hip replacement surgery. This is a procedure in which the original hip is removed and replaced with a synthetic one made of plastic, ceramic, and metal materials.
During the surgery, the doctor removes the damaged femoral head, which is the round part at the top of the thighbone that fits inside the hip socket. A new, synthetic femoral “stem” is driven into the top of the thighbone. A metal or ceramic “ball” or “femoral head” is placed on top of this femoral stem, replacing the round part of the bone that was removed.
Next, the damaged cartilage is removed from the hip socket and replaced with a metal socket, called the “acetabulum.” Finally, a plastic, ceramic, or metal “spacer” is placed between the new ball and socket to create a smooth gliding action.
This is the basic procedure, and can be accomplished by using a number of different components made by different manufacturers. Hip resurfacing surgery is a related procedure that is basically the same, except that instead of removing the femoral head, the surgeon leaves it in place and simply trims and caps it with a smooth covering so that it fits well inside the new hip socket.
Metal-on-Metal Hip Implants Linked with Increased Risk of Complications
The Food and Drug Administration (FDA) has warned about the unique risks associated with so-called “metal-on-metal (MoM)” hip implants, which place at least two metal components next to one another. These were originally designed to resist wear and tear and to last longer, but real-world use revealed that they did not perform as expected.
Unlike hip replacement devices that place ceramic or plastic components next to the metal ones, MoM implants place metal components next to metal components, which over time, can result in fretting and corrosion. As the components move and slide against each other, they can shed tiny metal fragments into the surrounding tissue of the joint, causing problems like the following:
- Pseudotumors (pockets of fluid)
- Inflammation and swelling
- Tissue damage and/or death (necrosis)
- Pain and difficulty walking or getting up from a seated position
- Weakening of the metal components
- Increased risk of hip loosening or dislocation
- Early implant failure requiring revision surgery
That corrosion can also cause metal ions to seep into the bloodstream, which can create a condition called “metallosis,” or metal poisoning. This creates symptoms including the following:
- Nerve tingling, numbness, and damage
- Skin rashes
- Tinnitus (ringing in the ears)
- Hearing and visual impairments
- Cognitive impairment
- Kidney problems
- Thyroid problems
- Cardiovascular problems, including cardiomyopathy
After these products came onto the market, a number of scientific studies showed they were more dangerous than other types of implants. In April 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert advising doctors to regularly follow-up with patients implanted with MoM hip devices because of their unique risks. Other organizations followed suit, including the FDA, Health Canada, and the Therapeutic Goods Administration of Australia.
Hip Implant Manufacturers Sued Over Defective Devices
Manufacturers are responsible for making sure their products work as advertised, and must also warn doctors and patients of any safety risks associated with them. Those that don’t often end up defending themselves in court when injured patients come forward seeking justice.
One of the main problems discovered with MoM implants was that they weren’t properly studied before they came onto the market. Though the FDA requires clinical studies on many new medical devices, if a manufacturer can prove that their device is substantially similar to one already on the market, they can use the FDA’s 510(k) fast-track approval system to bypass the clinical trial requirement and rush their product to market.
Many hip replacement system manufacturers did just that, only to find out later that their products were defective. Meanwhile, they earned millions of dollars in profits at patients’ expense.
To recover damages, thousands of patients have filed hip implant lawsuits against these manufacturers, in some cases creating large consolidated litigations in which one judge was appointed to oversee the pre-trial proceedings. Some of these litigations have already resulted in large settlements for patients.
Hip Replacement Products Linked with Increased Risks of Complications
Types of hip replacement systems that have been identified with increased risks of complications, or that have been recalled because of higher-than-normal revision rates, are listed below:
This manufacturer initially advertised their M2a Magnum MoM hip implant as ideal for younger individuals because it was supposedly more durable. By the time it had been on the market for several years, however, hundreds of patients had filed reports of problems with the device. It was never recalled, but Biomet has had to defend numerous lawsuits concerning the device.
Makers of the Pinnacle and the ASR XL Acetabular and Resurfacing MoM Systems, DePuy is a subsidiary of Johnson & Johnson (J&J), and has had to defend thousands of lawsuits concerning these hip replacement devices. The ASR devices were recalled in 2010, but the Pinnacle devices never were, though they were discontinued in 2013.
Smith & Nephew:
Makers of the R3 Acetabular hip replacement system, Smith & Nephew also received reports of higher-than-expected rates of revision surgery associated with their device. In this case, it was the metal lining at the top of the femoral head that was rubbing against the ball component and creating corrosion. The company recalled this system in 2012. Later, in 2016, they set out an urgent field safety notice also recalling their Modular SMF and Modular REDAPT Revision femoral hip systems because of higher than anticipated complaints.
Makers of the Rejuvenate and ABG II MoM hip replacement systems, Stryker is also defending hundreds of lawsuits filed by plaintiffs who claim to have been injured by their products. Because of a higher-than-expected number of reports of failure associated with these systems, Stryker recalled them both in 2012. Later, they had similar problems with their LFIT Anatomic CoCr V40TM femoral heads, which received higher than normal complaints of taper lock failure—weakening and corrosion around the junction between the femoral stem and the femoral ball. In 2016, Stryker released an urgent medical device notification recalling certain sizes of this component.
Makers of the Conserve and Profemur hip replacement systems, Wright’s products have also been linked to serious complications like instability, metal toxicity, pain and immobility, and premature failure. Wright has not recalled these devices, but they’ve had the same issues with them. While the Conserve is a MoM design with all the usual problems, the Profemur has been linked to higher-than-expected rates of revision surgery because the femoral neck is vulnerable to degradation, fractures, and breaks.
Makers of the Durom Cup hip replacement system, Zimmer was one of the first hip replacement companies, along with DePuy, to face the consequences of designing a defective product. In 2008, they had to recall the Durom Cup because of numerous reports of loosening and required revision surgery. They created a new surgical training program, then returned the product to the market with updated instructions. Zimmer later paid millions of dollars in compensation for injuries.
Experienced Hip Implant Lawyers
If you or a loved one was implanted with a hip implant device that later failed and required revision surgery, call us today for a free consultation. Chaffin Luhana is now investigating these cases, and will not charge you unless we recover damages for you. Call today us at 1-888-480-1123.