All hip replacements come with risks and if your doctor thinks a replacement could help you function better, he or she will review your options prior to your final decision about a replacement. However, the risk is higher with some replacement products and in some cases, products have undergone consumer recalls and their manufacturers are involved in pending litigation. Smith & Nephew is a London based company that manufactures hip replacement products and has been named in several lawsuits regarding the safety of their products.
R3 Acetabular System and the Metal Liner
After discovering consumers were experiencing difficulty with the R3 Acetabular System, Smith & Nephew issued a market recall for the metal liner component of the devices. Consumers and surgeons found revision surgery was needed in a higher than expected rate with these systems and on June 1, 2012 the recall was initiated. R3 Acetabular Systems are still in use and the company recommends physicians carefully monitor patients to ensure the in-use devices are not malfunctioning.
In the United States, the R3 Acetabular System is used as a total replacement system component and is not cleared for use with the metal liner. The liner is only approved for use with the Birmingham Hip Resurfacing System, so even if you do not have the R3 Acetabular, you must still be aware of the risks with the liner.
As of July 22, 2013, the US District Court for the Northern District of Illinois rejected Smith & Nephew’s assertion that claims regarding quality control issues were pre-empted by federal law. The plaintiffs filing suit against Smith & Nephew claim the company was negligent and is liable for problems with the Birmingham Hip Resurfacing System. The judge officially ruled that the plaintiffs’ claims of negligence and strict liability involving alleged quality control issues in the Birmingham Hip Resurfacing System may go forward. Many people are still in the process of seeking legal representation concerning their complications and the decision is viewed as positive for the victims.
Why Should You File a Lawsuit Regarding the R3 Acetabular System or the Metal Liner?
People who have experienced issues with the metal liner of the R3 Acetabular system or the Birmingham Resurfacing System are encouraged to take action. The liner is constructed from chromium and cobalt metals. Implants made from these materials are known to release metal ions into the body, which are carcinogenic.
Other problems include:
- Tissue irritation
- Damage in the area near the implant, which can eventually destroy the muscle and bone
- Loosening of the implant
- Metal toxicity
- Blood poisoning
- Cardiomyopathy related to exposure to cobalt
Both Australian and UK studies found that patients with the metal liner implants did not suffer metallosis as a direct result of implantation, but some did experience complications related to loosening of the device that eventually led to metallosis.
It is also important to note that R3 Acetabular Systems fitted with ceramic liners have not undergone any recalls, but the FDA did issue a warning in 2010 concerning the ceramic component. The warning was based on Smith & Nephew’s failure to document manufacturing procedures, such as machine settings and sterilization.