In June 2012, Smith & Nephew recalled the metal socket liner used in its R3 Acetabular hip system. The R3 metal liner was introduced to the market in 2009. It is estimated that about 7,700 have been implanted in patients since 2009. Smith & Nephew claimed that it was “not satisfied with the clinical results” of the liner. It is reported that patients have experienced adverse side effects from the R3 metal liner including infections, dislocations and fractures. There has also been a higher rate of revisions due to evidence of metallosis or metal ion debris.
The clinical data upon which Smith & Nephew is basing its withdrawal of the R3 from the market is the fact that 1.6 % of patients with the R3 will require revision surgery each year. This is above the 1% guideline that has been set by Britain’s National Institute for Health and Clinical Excellence.
The United Kingdom’s Medicine and Healthcare Products Regulatory Agency (MHRA) has issued a medical device alert relating to the recalled R3 metal liner. The alert addressed the “increased rates of revision of MOM hip replacements when using the metal liner component of the R3 acetabular system.” The alert also addressed the fact that the revision percentage associated with the R3 metal liner is not in line with its guidelines. The MHRA asks that patients who have been implanted with R3 metal liner components undergo annual follow up for the life of the implant regardless of whether they are experiencing signs of failure. Importantly, the MHRA is asking that all patients undergo blood testing for metal ion levels which has been a common issue associated with metal-on-metal hip implants, particularly recalled or failed metal-on-metal devices.
Some of the common side effects and complications that might arise from having a recalled or failed R3 metal liner include:
This recall follows in the footsteps of the Zimmer Durom hip implant recall in 2008 and the disastrous DePuy ASR metal-on-metal hip implant recall in August 2010. The recall of the R3 metal liner is the second recall of a metal hip component in 2012. On July 6, 2012, Stryker recalled its Rejuvenate and ABG II modular neck stems in the United States.
Metal-on-metal hip implants continue to pose significant health risks to patients who undergo implantation of these devices. The FDA has expressed serious concern about the benefits of metal-on-metal hip implants and recently asked 21 manufacturers to conduct research on the effects of metal debris and ions on patients with these implants.
A number of lawsuits have already been filed against Smith & Nephew. Patients who have received a defective Smith & Nephew hip implant are finding that the only way they can receive compensation for their injuries is to file a lawsuit against Smith & Nephew.
Once a preliminary evaluation is done on your case, you will receive a packet. The packet contains a contract, questionnaire and authorization. This information is necessary to further evaluate your claim and to obtain your medical records. Obtaining your medical records can take 3o to 60 days. After the medical records are retrieved, an attorney will review your records and a determination will be made on your case.
If your case is accepted, a lawsuit will be filed. Pharmaceutical and medical device cases are frequently grouped together or “consolidated” in one court before one judge. This helps the discovery process proceed more quickly and efficiently. These consolidations are known as “MDLs” or Multi-District Litigation. An MDL is not a class action. Your case will be evaluated, tried and ultimately settled on the merits of your particular case.
If you’ve been harmed by a defective Smith & Nephew hip replacement, speaking to a qualified lawyer experienced in handling medical device cases is your best course of action. An attorney from Pierce | Skrabanek will provide a free case evaluation and analyze the facts of your case. We handle all cases on a contingency basis, meaning that we don’t get paid unless we win.