Wright Conserve, Lineage, and Dynasty Hip Systems
The Wright Conserve, Lineage, and Dynasty hip systems are three different versions of acetabular component parts designed by Wright Medical that consist of metal-on-metal make up. Patients with these devices were reporting pain, metallosis, and need for revision only shortly after the devices were implanted. While Wright never officially recalled these products from the U.S. market, in 2010, a multidistrict litigation was formed in the Northern District of Georgia to hold the company accountable for the failure of their products.
After years of litigation, in 2016, the parties announced a global settlement to compensate victims with the Wright Conserve, Lineage, and Dynasty hip products. Wright Medical agreed to pay over $60 million in settlement funds to those harmed by these products. This global settlement continues to be underway.
Wright Profemur Hip Systems
From the early 2000s to the present day, Wright Medical has sold the Wright Profemur hip product on the U.S. market. The Profemur hip consists of a neck and stem. It is a modular component, made up of two pieces, similar to the Stryker Rejuvenate device. Until 2011, Wright Medical actively sold a titanium neck version of this product. There have been reports of several fractures of the titanium Profemur neck device from fretting and corrosion at the neck-stem interface. In 2009, Wright introduced a cobalt and chromium (CoCr) version of the Profemur neck onto the U.S. market. There are also reports of fretting and corrosion of the Profemur CoCr modular neck.
Biomet M2A Magnum Hip Systems
In 1996, Biomet released a line of hip products it called the Biomet M2A Magnum hip devices. This hip system consisted of the cup, liner, and ball of the hip device, or the acetabular pieces. These pieces consisted of metal-on-metal parts. Reports of early failure rates were made by hundreds of patients throughout the country regarding this hip implant.
In 2011, a multidistrict litigation was consolidated against Biomet in the Northern District of Indiana. In 2014, Biomet agreed to pay $56 million in total settlement to compensate victims of the product. Over 2,000 cases were filed.
Zimmer Hip Systems
Zimmer Durom Cup
In 2006, Zimmer introduced the Zimmer Durom cup onto the U.S. Market. The Zimmer Durom cup is the metal cup that is placed on top of the artificial hip ball. Only two years after releasing the Durom cup onto the U.S. Market, Zimmer recalled the product due to reports of early failure. Because it was only a partial recall, the product was still subsequently sold. Not only was there a metal-on-metal part make up resulting in dangerous reports of metallosis, but the device was also loosening, requiring revision surgery.
A multidistrict litigation was consolidated against Zimmer in the District of New Jersey. After several trials with mixed results, Zimmer agreed to resolve lawsuits for those who had to undergo a revision of the Durom cup less than nine years after implant.
Zimmer M/L taper and the Zimmer Kinectiv Hip Systems
The Zimmer M/L taper and Kinectiv hip systems are comprised of the femoral components of an artificial hip device. The devices are designed to be made up of two pieces, the neck and stem, not dissimilar to the Stryker Rejuvenate model. While these devices are still on the U.S. market, there have been reports of early failure associated with corrosion and metal wear at the neck-stem interface requiring revision.
Additional Defective Hip Resources
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Metal-On-Metal Hip Implants
Hip joints deteriorate for various reasons. When this happens, hip replacement is one option for patients who still want to lead an active lifestyle. The artificial hip is a simple ball-and-socket joint. All total hip replacement systems consist of a ball (femoral head), stem (femoral stem), and cup (acetabular component). The device works by securing the stem inside the femur bone. The ball connects to the stem which is then aligned and sized to fit inside a cup on the hip bone, acting as the artificial hip joint. All components must be durable and sturdy, therefore metal, plastic (polyethylene), and ceramic are commonly used to make artificial hip components.
Until recently, one popular combination of artificial hip device parts included metal parts placed next to each other. Whether it be the metal ball placed next to the metal cup, the metal ball placed next to the metal neck, or other metal-on-metal combinations, these metal-on-metal placements have the capacity for problems.
How Are These Hips Failing?
The advantage of modular metal-on-metal hip implants is that they are customizable. Because there are a variety of neck sizes and angles, the Surgeon has the flexibility to implant a neck that is the best fit for the patient. The disadvantage of modular metal-on-metal hip implants is that there is now one more place for metal to rub against metal, leading to corrosion of the metal components. Corrosion of this neck/stem juncture causes further release of metallic particles, negative reactions with the tissue, and often ultimately requires revision surgery. A May 2016 study in the Journal of Arthroplasty recently concluded that the high prevalence of severe taper corrosion may be related to elevated cobalt and chromium levels in the patient before revision surgery takes place.
Dissociation of the hip implant occurs when the components fall apart or disconnect. This type of complication occurs most in hip implants with large modular femoral heads. A large femoral head can place a large amount of stress on the taper-neck junction where the ball connects to the neck of the femoral stem. As a result, fretting and corrosion of the taper become more likely due to the design of the implant. If there is too much fretting and corrosion between the head and taper, the system falls apart, setting the patient up for a less than pleasant experience.
Acetabular Component Failure
An artificial acetabular system includes the cup, sometimes liner and ball of the artificial hip joint. The acetabular components fail for similar reasons as the taper lock. When adjacent pieces of the acetabular system are metal, the metals can rub together with movement, resulting in metal wear, corrosion, and metallosis. This metal-on-metal wear can damage the tissue and muscle around the hip device, causing metal to be released into the body, including the bloodstream, and can cause loosening, or device repositioning, severe pain and often a required removal surgery. This can also lead to a painful dislocation of the hip from its socket, which is an experience most people would not wish on their worst enemy.
Metal Poisoning (Metallosis)
One way in which hip replacement failure occurs is through metallosis. Because metal-on-metal hip implants are made of metal materials, metallic ions and particles, often from the cobalt-chromium components, can cause major medical issues for the patient. The shedding of cobalt and chromium in the bloodstream is relatively harmless to some, but extremely harmful to others. Even if you have metal poisoning (metallosis), it is not always painful, so you may not immediately feel it or know that it is happening. This is why it is important to ask your doctor to test your blood for cobalt and chromium levels if you have a metal-on-metal hip implant.
Bone and Tissue Damage
Metal particles contaminate the tissue and bone surrounding the hip implant. In some individuals, their body has a negative reaction to the metal particles known as adverse local tissue reaction (ALTR). When this happens the bone and soft tissue become damaged leading to other problems like implant loosening, device failure, and the need for a revision surgery.
When soft tissue surrounding the hip implant reacts adversely legions called pseudotumors can begin to form, but they are not always noticeable to the patient.
In a revision surgery, the surgeon replaces the existing hip implant with a new one. Revision surgery is a gruesome process where the device is literally chiseled and hammered out of the surrounding bone and soft tissue.