Smith & Nephew R3 Hip System Linked to Severe Injuries
What should I watch out for?
Modern artificial hip systems were created to accommodate younger patients by eliminating the issue of device failure due to overuse. However, the construction of the hip implants has raised concerns.
The U.S. Food and Drug Administration (“FDA”) is investigating several injuries caused by hip implant devices. Smith & Nephew R3 Acetabular hip systems have been recalled due to their high failure rate coupled with reports of patients experiencing severe side effects, including metal poisoning and bone damage.
What complications do Metal-on-Metal hip implants cause?
Hip replacement systems replace the hip’s ball and socket. Metal-on-metal hip systems are systems where a metal ball fits into a metal socket to form the replacement joint. Complications caused by the friction of the two metal parts include:
- Metal blood poisoning
- Metal sensitivity
- Bone fracture
- Device loosening
- Tissue damage from metal debris
- Hip pain
- Nerve and muscle damage
- Earlier than normal failure of the hip replacement
- Implant failure
- Revision surgery
Metal blood poisoning, or metallosis is a buildup of metal in the body. It can be toxic and lead to serious complications affecting the skin, nervous system and other organs. Symptoms of metal poising include:
- Skin rash
- Sensory changes
- Psychological changes
- Thyroid dysfunction
- Renal function impairment
Patients who have undergone total hip replacement or resurfacing surgery and were implanted with the Smith & Nephew R3 system should contact their physician immediately if any of the above-mentioned symptoms are noted. Health-care physicians will likely test their blood for cobalt and chromium. Abnormal levels of cobalt and chromium levels are 0.3 micrograms per liter (mg/l) or more.
Which hip device manufacturers make metal-on-metal hips?
There are numerous hip device manufacturers. The most common are:
- Smith & Nephew
Who makes the R3 replacement system?
Smith & Nephew, a U.K.-based medical technology company, introduced the R3 Acetabular System into the orthopedic market in 2009. The R3 Acetabular System is a modular hip implant system, meaning that the surgeon can choose the individual components based on the needs of the patient. These components come in plastic, metal and ceramic.
Tell me more about the Smith & Nephew R3 hip system.
Most hip implant systems have several components: the acetabular cup (also known as a shell), liner, femoral head and stem. The cup replaces the acetabulum, or hip socket. The liner fits in between the cup and the femoral head. The R3 Acetabular System includes an acetabular cup made of plastic, metal or ceramic; a femoral head made of OXINIUM, cobalt chrome or Biolox ceramic; and a liner made of OXINIUM, metal, ceramic or XLPE plastic. These pieces can be combined with several types of stems, allowing the surgeon to tailor the system to the patient.
The metal liner featured in the system is made of high carbide cobalt chrome (CoCr), which the company claims is designed to reduce wear rates and provide optimal friction reduction. In addition to the CoCr liner, the R3 system comes with a polyethylene (plastic) liner. Smith & Nephew’s design allows the liners to fit better in the cup, which ideally should enhance range of motion while decreasing the risk of loosening, nerve impingement and dislocation.
When used with the metal liner, the R3 Acetabular System can become a metal-on-metal implant. Like other companies that manufacture these types of implants, Smith & Nephew marketed the metal liner option of the R3 Acetabular System as durable and wear-resistant. However, instead of long-lasting durability, an alarming number of these implants have failed prematurely. Also, they may present additional complications like metallosis (metal poisoning) that stem from small metal particles entering the body.
About 7,700 R3 devices have been implanted worldwide since 2009. The device experienced a higher than normal revision rate — 6.3 percent in four years compared with the average of 2.89 percent for primary total hip replacements.
Smith & Nephew issued a worldwide, voluntary recall of the metal liner in the R3 Acetabular System in June 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. In the recall, Smith & Nephew stated that the metal liner was not “performing as well” as the company expected and that it was “not satisfied with the clinical results.”
What hip device models are metal-on-metal hips?
Metal-on-metal hip implants are for active, younger individuals who want to restore mobility and increase their quality of life. Metal-on-metal hip replacement systems are advertised as more durable hip implants that last longer than the hip replacement devices already on the market, such as ceramic-or-ceramic models or metal-on-polyethylene (plastic) models.
Some metal-on-metal hip device systems include:
- Biomet M2A
- DePuy ASR
- DePuy Pinnacle
- Omni Apex K2
- Smith & Nephew Birmingham
- Smith & Nephew Redapt
- Smith & Nephew R3 Acetabular
- Stryker ABG II
- Stryker Accolade
- Stryker LFIT V40
- Stryker Rejuvenate
- Wright Conserve Plus
- Wright Profemur
- Zimmer Durom Cup
- Zimmer M/L Taper
- Zimmer Versys
Are there ongoing concerns with Metal-on-Metal Hip implants?
There have been a lot of new articles, adverse event reports, studies and press releases surrounding metal-on-metal hip implants. The FDA held an advisory panel meeting in June 2012 to analyze many adverse event reports received regarding metal-on-metal hip devices. As part of its investigation, the FDA asked major hip device manufacturers to conduct long-term, follow-up studies of more than 100 metal-on-metal hips.
In recent years, several metal-on-metal hip replacement manufacturers have reached settlement deals to end countless lawsuits alleging severe complications caused by the defective hip devices. The lawsuits claim the device companies designed and sold a defective device, the device companies knew or should have known about the hip implant problems, and the device companies failed to warn the public about known risks with the devices.
Be on Watch
If you or a loved one had a hip device implanted since 2000 and experienced symptoms, you may qualify for financial compensation for medical expenses, medical treatment, loss of income, and injuries suffered.
Call us at (800) 684-2136 or send us an email inquiry to discuss your legal options.
The consultation is free and confidential.
- FDA concerns about Metal-on-Metal Hip Implants https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
- Reuters metal allergies article June 20, 2014 https://www.reuters.com/article/us-joint-replacements-metals-allergy-idUSKBN0EV1TY20140620
- The New York Times hip implant failure article January 22, 2013 https://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0