Wright Medical Technology, Inc.,makes several hip implant products, including some that fall into the category of metal-on-metal hip replacement devices. These include the CONSERVE line, consisting of CONSERVE Plus Total Hip Resurfacing System, CONSERVE Total Hip with BFH Technology and CONSERVE Total A-Class Advanced metal with BFH technology.The company’s Profemur Z Stem is another of its metal-on-metal hip implant products.
Like all metal-on-metal devices, the products made and sold by Wright Medical have been the subject of complaints from patients. In addition to a high failure rate requiring additional corrective surgeries, metal-on-metal hip implant products can result in the release of metal ions in the body that cause serious complications.
If you or a loved one has been injured as a result of the CONSERVE or Profemur Z Stem products sold by Wright Medical, you could have a right to compensation. An experienced defective medical device attorney at Roberts & Roberts can review your situation,explain your legal options and help you take appropriate legal action.
About Wright Hip Replacement Products
Hip implants or hip replacements allow patients to replace damaged hip joints with a new artificial joint. Normally, this procedure involves placing a cup inside the acetabulum, which is an indentation in the pelvis that the joint fits in. A new joint is then fashioned and attached to the femur by carving out the inside of the femur and putting a stem inside of it.The cup, its liner, and the joint are made of a variety of materials including ceramic, polystyrene and metal.
Some of the products sold by Wright are classified as ceramic-on-ceramic hip implant products.These include LINEAGE liners, which have ceramic acetabular cups and femoral heads. The ceramic products sold by Wright have been less problematic.
In the 2000s, metal-on-metal hip replacement products, consisting of a metal cup and a metal replacement joint,became very popular as an alternative to ceramic implants. Many manufacturers began selling them, including Wright Medical.
The metal-on-metal hip replacement devices were brought to the market with minimal testing under 510(k) rules. These rules allow for a relaxation of normal FDA standards so that devices can obtain fast-tracked approval with almost no testing required. 510(k) rules allow this speedy path to the marketplace for medical devices substantially similar to those that have been already approved.
Unfortunately, a lot of dangerous devices ended up coming to market largely untested as a result of the 510(k) rules, which allow for approval based even on a problematic existing device as long as there had been no FDA-mandated recall.
The metal-on metal hip implants by Wright and other manufacturers were one such dangerous class of products. Metal-on-metal implant systems were marketed largely to young and active people who wanted the greater range of motion and the longer life that they purported to provide.
The Dangers of Metal-on-Metal Hip Implants
Wright’s metal-on-metal hip implant devices consist of a high-carbon chrome-cobalt acetabular cup and a chrome-cobalt ball joint.The cup and the liner of the cup come as one piece, and the cup is designed to encourage the pelvis to grow and fuse to the cup to hold it in place.
A variety of Wright Medical stems are available for insertion into the femur to hold the ball in place with both the CONSERVE and the Profemur Z systems. Different necks can be used, and the PROFEMUR system offers a modular neck, which promises a better fit but which may compromise the integrity of the hip joint.
Both the CONSERVE system and the Profemur Z system have their own problems.
The CONSERVE system can result in the release and build up of metal ions in the body as the metal parts of the joint implant rub against each other and degrade.
Metal ions in the body can cause:
- Metallosis, a buildup of ions that can damage the kidneys, muscles, liver, lymph nodes, thyroid, heart and nervous system
- Osteolysis, or a breakdown of bone
- Nerve damage or neurological problems
- Pseudo-tumors, or a build-up of fluid and metal parts.
Although not recalled, the Wright Products have a very high failure rate like the recalled DePuy Orthopaedics products. In the 2011 Eighth Annual Report published by the National Joint Registry for England and Wales, Wright CONSERVE Plus was compared with other hip implant systems, including DePuy brand products.After one year, 1.9 percent of patients with a Wright system needed a revision surgery. After three years, 4.29 percent needed a revision surgery. After five years, 7.99 percent of Wright hip recipients had been forced to undergo corrective surgery.Only DePuy had a higher revision rate.
The Profemur Z doesn’t fare much better in studies, with the Australian National Joint Registry reporting that 1 in 9 patients who had the device implanted needed a revision surgery due to failure.
Patients who experience any of the complications, from failure of the hip implant system to buildup of metal in the body, may be in significant pain and may suffer serious health consequences.
Symptoms of problems can include:
Some of the symptoms, such as hip pain or limited mobility, may go away after a revision surgery.Other complications and problems — such as nerve damage, for example — may be permanent and may reduce quality of life.
Legal Action over Injuries from Wright Hip Products
Multiple injured plaintiffs have filed lawsuits against Weight Medical Technologies, and you, too, may be able to take legal action if you or a loved one suffered harm as a result of a Wright metal-on-metal hip implant device.
The defective medical device attorneys at Roberts & Roberts are currently investigating claims related to hip implants and hip replacements. For a free, confidential review of your claim, call us today at 903-597-6000 or contact us online. The call costs you nothing... It could mean everything.