Wright Medical Hip Replacement
Wright Medical Group, Inc., whose subsidiary division OrthoRecon manufactured the Conserve and Profemur line of hip replacement components, is a global leader in the design and production of orthopedic repair and reconstruction devices. Wright sold its OrthoRecon business to MicroPort Scientific Corporation in January 2014.
While Wright Medical Group maintains a strong position within the orthopedic industry, it has faltered at times in producing well-engineered hip orthopedics. Some of Wright’s hip products have been reported to suffer premature failure and cause metal toxicity as the metal-on-metal hip prosthetics abrade one another.
Wright hip implants are used to replace a diseased, impaired or painful hip joint. Like all hip replacement products, Wright’s Conserve line of hip prosthetics were intended to decrease pain, boost mobility, and improve general quality of life. This product was designed as a metal-on-metal hip prosthetic which would be more durable than ceramic or plastic alternatives.
Unfortunately, the metal-on-metal design of some Wright hip replacement devices and other brands has prompted the FDA to issue a warning about complications including pain, implant loosening, device failure and the need for revision surgery. Initially designed as a durable orthopedic device, the Conserve hip prosthetic and products like it have received criticism from the FDA because these all-metal hip implants are prone to fretting and corrosion over time.
As the metal components wear down, the patient may experience excessive heat and pain from damage to surrounding bones and soft tissue. Furthermore, the metal may leach into the blood causing cysts, rash, heart problems, and tissue death. Other design issues intended to add flexibility and adjustable length have reportedly led to difficulty standing or walking, fracturing of the device, and loosening of joint components.
Wright Medical Group, Inc.
Originally founded more than 60 years ago, Wright Medical Group, Inc. currently manufactures a variety of devices and products for hip, knee, foot, and ankle repair or reconstruction. WMGI also offers a selection of products for shoulder, elbow and wrist reconstruction as well as biological products like bone graft substitutes. With operations in over 60 countries and more than 1,400 employees working in its design, manufacture, and distribution divisions, Wright Medical Group is a key manufacturer of orthopedic products.
WMGI currently has a market size of $3.5 billion with a market capitalization of $1.2 billion and sales of almost $237 million for 2013.
Wright’s line of hip replacement products
Wright Medical Group’s flagship product for many years has been its line of Conserve hip replacements, although it also produces the Dynasty, Gladiator, Lineage, Perfecta and Procotyl hip replacement devices. The Conserve hip implants are constructed from cobalt chrome alloy, stainless steel, polyethylene, and silicone.
Wright hip replacement prosthetics primarily consist of a metal socket which is similar to a cup in design, with a second rounded, metal femoral stem that is meant to fit snugly within the socket. The rounded end of the femoral stem, which has the commercial name Profemur, may come in various sizes to fit the anatomy of the patient while the length of this component may be adjusted by the surgeon manually. The Profemur component, constructed from titanium and titanium alloy, was also designed to be pliable, allowing patients more flexibility in movement.
Problems with Conserve and Profemur implants
Wright designs and manufacturers the following products, some of which are currently the subject of pending lawsuits:
- Conserve Total Hip System
- Conserve Total Femoral Head
- Profemur E Cementless Stem
- Wright Profemur Z Femoral Stem
- Conserve Plus Total Resurfacing Hip System
- Conserve Plus Cup
- Conserve Total A-Class Advanced Metal Hip Implant System
- Conserve Femoral Hip Surface Replacement
The Conserve and Profemur lines have been linked to serious hip replacement complications in patients. The flexible neck of the Profemur component has been known to fracture, which can result in inflammation, pain, and difficulty walking; breaks in the femoral stem often necessitate a revision surgery. The Conserve hip replacement has a metal-on-metal ball and cup design. Over time, the two metal components can rub against one another producing metal particles that enter the blood or deposit in nearby tissue. This may produce immediately recognizable symptoms like swelling, pain and limited mobility, but the most serious issue is the damage that can be done to vital organs.
The metal poisoning that may result from these Wright hip replacements is a side effect of cobalt and titanium ions leaching into the patient’s bloodstream. Once in the blood, these particles can travel to the heart, brain, skeleton and nervous system.
Over time, patients can suffer debilitating and painful conditions such as:
- Loss of mobility
- Difficulty standing and walking
- Tissue necrosis
- Hip fractures
- Loose joints
- Heart problems
- Vision problems
- Hearing problems
Patients who have had a Wright hip replacement surgery are strongly urged to have regular x-rays and blood testing. If elevated levels of cobalt or titanium are found in the blood, most patients will require a revision surgery to replace the current hip prosthetic.
Metal hip products may be poised for a recall
Although a Wright hip recall has not been issued, mounting concern over metal implants along with increasing litigation suggest that such actions could be imminent. In June 2012, the FDA published a report that almost 16,800 adverse events related to metal-on-metal hip implants have been reported in the U.S. between 2000 and 2011. After convening a panel to discuss the need for metal-on-metal hip replacements, the panel concluded that patients should avoid these products and opt for ceramic or plastic alternatives. The FDA has not yet moved forward on a possible recall.
Wright hip lawsuit status
As a result of purported design flaws in their products, the manufacturer is currently facing numerous Wright hip lawsuits, in which plaintiffs make allegations that the Conserve and Profemur hip replacement systems have caused serious injuries stemming from metal toxicity, premature failure and other complications, forcing patients to undergo revision surgery.
Due to the rising number of Wright Medical hip lawsuits involving the Conserve hip system, a panel of federal judges consolidated qualifying actions into a multidistrict litigation in the U.S. District Court of the Northern District of Georgia (MDL 2329). At least one Wright hip lawsuit involving the Profemur hip replacement system in California has reached a settlement as of March 20, 2013. Patients who have taken legal action against Wright Medical are demanding monetary damages for related medical expenses, lost wages, pain, suffering and other economic losses.
- U.S.District Court, Northern District of Georgia, In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL 2329 http://www.gand.uscourts.gov/mdl/wright_medical.html/
- FDA, Safety Communication on Metal-on-Metal Implants http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm
- Wright Medical, Conserve Family of Hips http://www.wmt.com/ConserveFamily/