Over 330 thousand hip replacement surgeries are performed every year to replace worn or damaged hip joints with an artificial joint. Though some joint replacement surgeries are done due to accidental injury, in most cases, hip replacements are performed because the joint has simply “worn out”.
Though most surgeries are successful, thousands of patients have faced serious harm due to poorly designed or defective joint replacement products. Several top device manufacturers are facing tens of thousands of hip replacement lawsuits for injuries caused by their artificial joint products.
Hip Replacement Device FDA Complaints
A large percentage of hip replacement failures have been reported to the U.S. Food and Drug Administration (FDA). Most of these failures may have been caused by to the design of certain devices with Metal on Metal (MoM) design. Unlike devices made with plastic components MoM, allows for the components to grate against one another producing metal ions which may be toxic.
Other device failures may be caused by Metal on Plastic (MoP) devices which allow for shedding of plastic particles into the joint or may be caused by dislocation, detachment, or degradation of the artificial joint.
The models of hip replacement devices most commonly included in FDA complaints include:
|DePuy Orthopaedics (Johnson & Johnson)||Pinnacle Hip Replacement System
ASR XL Acetabular System
ASR Hip Resurfacing System
|Stryker Corporation||Rejuvenate System
ABG II System
Metal V40 Femoral Head
Tritanium Acetabular Shells
|Zimmer Biomet||Zimmer Durom Acetabular Component (Durom Cup)
Zimmer M/L Taper Hip and Versys Femoral Head
Biomet Magnum M2A
|Smith & Nephew||R3 Acetabular System
Modular SMF Hip System
Modular Redapt Revision Femoral Hip System
Birmingham Hip Implant
Emperion Hip System
|Wright Medical (MicroPort Medical)||Conserve Total Hip Implant System
Conserve Total A-Class Advanced Metal Hip Implant System
Conserve Resurfacing System
Lineage Hip Implant System
Dynasty Hip Implant System
Profemure Z Stem Hip Device
Thousands of lawsuits have been filed because of hip replacement devices which caused medical injuries, the need for revision surgery, permanent disability and even death. Some of these lawsuits have been settled but many more remain in federal, state, and local courts and more lawsuits may be expected.
What is Hip Replacement Surgery?
When a hip joint has worn out due to overuse or age or has been damaged through injury or medical causes, hip replacement surgery can relieve pain and restore functioning and mobility by replacing damaged or worn bone and tissue with artificial replacement components.
Hip replacement surgeries can involve either the removal and replacement of the entire joint or the removal and replacement of only a part of the joint. Partial replacement can be done on the “ball” of the hip joint or femur head, or it can be done on the “socket” portion of the hip joint, also called the acetabulum. In less severe cases, some patients will undergo “hip resurfacing” in which an artificial cup is placed in the socket portion of the acetabulum and a cap is placed over the femur head.
Hip replacement surgeries have restored mobility to hundreds of thousands of patients, but thousands of patients have not had positive results. Hip replacement procedures can cause a number of side effects, some of which are severe. The FDA has received thousands of complaints and severe adverse event reports involving a number of faulty hip replacement devices. Multiple manufacturers have faced lawsuits for injuries caused by their artificial joint implants.
Hip Replacement Side Effects
Any medical procedure may result in side effects, including hip replacement, and may go away after a period of recovery. Other side effects are more severe and warrant additional medical treatment.
Some of the common side effects include:
- Pain and inflammation
- Muscle loss
- Painful recovery
Side effects that are more severe are commonly the result of metallic or plastic debris which has been shed from the device and may lodge in the joint area. In addition to localized damage from plastic, or localized poisoning from metal fragments, the patient may also experience systemic or body-wide poisoning from metal ions which have entered the blood supply and result in an immune reaction.
Severe side effects may include:
- Osteolysis – bone dissolution
- Necrosis – bone and tissue death
- Pseudotumor formation – false tumor formation in surrounding tissue
- Bone fractures – due to weakened bones in hip or femur
- Joint dislocation – artificial joint loosens or separates from healthy bone
Most patients who experience serious side effects must undergo revision or replacement surgery to remove the faulty device and replace it with a new one. Some patients with extensive damage may also require one or more reconstructive surgeries to repair fractures or other bone deformities.
Hip Replacement Metallosis
Components of Metal on Metal (MoM) hip implant devices may grate against one another and allow metal particles to be shed into the surrounding tissue. When fragments are lodged in the joint tissue, a condition known as Metallosis develops and is a result of “poisoning” of the surrounding tissue. All faulty hip implant devices may shed metal fragments, but MoM devices are the worst offenders.
Many of the severe side effects of hip devices which show early failure rates can be attributed to Metallosis and most of these patients will be required to undergo revision surgery. Some may also require one or more reconstructive surgeries as well, depending on the severity of bone damage.
Very small metal fragments or ions may be absorbed into the bloodstream, causing an immune response and resulting in a series of flu-like symptoms such as:
- Body Aches
Systemic metal poisoning may also result in an immune crisis or even neurological damage due to brain swelling or damage which may be severe.
Hip Revision Surgery
When a hip device has shown early failure, severe complications may result. In most cases, the patient will be required to undergo another surgical procedure to remove and replace the faulty device.
Hip revision surgery is often much more invasive and painful than the original surgery and poses additional risks to the patient. Patients will often experience more pain and require a significantly longer recovery time.
If damage to previously healthy bone tissue is severe, patients may also be required to undergo reconstructive surgery to repair degraded or fractured bone with titanium screws and rods or with bone grafts. In many cases, a reconstructive surgery is required before the replacement or revision surgery. Each time the patient undergoes an additional surgical procedure, the risk of complications including infection, pain and lengthy recovery time will increase.
Hip Implant Shortcut FDA Approval Process
Most of the hip replacement devices available in recent years, including those still on the market, were approved using the FDA’s 510(k) pathway. This is a “shortcut” approval process which allows the manufacturer to skip costly clinical trials.
A manufacturer of a medical device is allowed to claim that the new device is similar to devices already on the market. This allows the manufacturer to market a new device without ever testing it in human subjects. Some experts have blamed the adverse event rate of MoM and other devices on this shortened pathway and have urged the FDA to close the 510(k) loophole.
Hip Replacement Recalls and Lawsuits
Several of the hip joint devices named in hip replacement lawsuits have been recalled. The majority of these are MoM type hip replacement devices and all of them were approved under the FDA 510(k) marketing pathway.
DePuy Hip Replacement Lawsuits – DePuy Orthopaedics, a subsidiary of the pharmaceutical giant Johnson & Johnson, manufactures three hip devices which have faced multiple recalls and resulted in thousands of medical injury lawsuits, primarily due to MoM construction. More than 20,000 lawsuits have been filed against DePuy. Thousands of these lawsuits have been settled for billions of dollars but some still remain in courts and more may expected. The company has also settled lawsuits with 46 states over improper marketing of hip implants.
Stryker Hip Replacement Lawsuits – Stryker Orthopaedics is the largest global orthopedics company and manufactured the first MoM device. Four hip replacement devices manufactured by Stryker have resulted in thousands of lawsuits against the company. Stryker has already paid billions of dollars to settle hip replacement lawsuits for their three of their products but more may be filed or remain in court systems.
Zimmer Biomet Hip Replacement Lawsuits – Biomet was acquired by another device company, Zimmer in 2015, but had already settled thousands of lawsuits for injuries caused by their devices. The company also faced claims that it was guilty of bribery in China, Brazil, and Argentina. Biomet and Zimmer have offered settlements reaching into the six-figure range and may be facing more lawsuits for hip replacement failure.
Smith & Nephew Hip Replacement Lawsuits – Smith & Nephew manufactured two devices with all metal construction and three additional products which have been the subject of hundreds of injury-related lawsuits. Several recalls have been issued due to high failure rate and the company has paid $40 million in U.S. Department of Justice fines for false claims and kickback schemes. The company is facing hundreds of hip replacement lawsuits, but no settlements have been announced and more cases may be filed.
Wright Medical Hip Replacement Lawsuits – Wright Medical Technology Inc. was acquired by MicroPort Medical in 2013. Prior to acquisition, Wright manufactured multiple types of hip joint replacement devices which resulted in early failure for many patients. Wright offered settlements to resolve an estimated 2,000 lawsuits between 2016 and 2019 and the company also paid $7.9 million to settle charges of bribery. MicroPort Medical continues to manufacture a number of hip replacement devices and may face additional lawsuits for injuries.
Hip Replacement Attorney
Hip Replacement Lawsuits filed against hip device manufactures claim that the companies constructed faulty devices, did not adequately warn the medical community and public about risks of the devices, and aggressively promoted their devices with many companies also accused of paying doctors to use them.