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The U.K.-based medical technology company Smith & Nephew has recalled multiple components used in hip resurfacing and replacement. In addition, the company has faced several lawsuits in the U.S. alleging liability for negligence, defective design and breach of implied warranty.
R3 Constrained Acetabular Liner Recall
In August 2010, Smith & Nephew sent recall letters to distributors and hospitals informing them of problems related to the company’s R3 constrained acetabular liner and recalling all outstanding stock. The letter also advised notification of all customers to inform them of the recall. The company sent a second recall notice in September 2010. The devices recalled had been distributed in the U.S., Australia and Portugal.
R3 Metal Liner Recall
In 2007, Smith & Nephew began producing and marketing optional metal cup liners for its R3 Acetabular System total hip replacement prostheses, and the company began distributing the component globally in 2009. In 2008, the U.S. Food & Drug Administration (FDA) approved the R3 metal liner for use with the Birmingham Hip Resurfacing System, but the liners were not cleared for use with R3 Acetabular total hip replacement systems.
After reviewing Australian and U.K. patient data indicating that the R3 metal liners were not performing as well as expected, Smith & Nephew issued a voluntary global recall of the liners in June 2012. The Smith & Nephew recall represented the third worldwide recall of metal-on-metal hip replacement components by medical device companies.
After reviewing results of clinical studies, Smith & Nephew found that 1.6% of hip replacement patients with the R3 metal liners needed revision surgery each year. This figure exceeds the 1% guideline set by the National Institute for Health and Clinical Excellence. In addition, according to aftermarket data, people who received the R3 metal liners as part of their hip replacement implants showed a revision rate of 6.3% within four years of the initial surgery.
Based on this data, on June 25, 2012, the Medicines and Healthcare Products Regulatory Agency (MHRA) — a U.K. government organization that regulates medical devices — advised doctors to discontinue using the metal liners for hip replacements. Similar warnings were issued by national and regional health and safety agencies in the U.S., Australia, New Zealand and other countries around the world.
Lawsuits & Complaints
In her complaint, Goldin alleged that as a result of her hip R3 acetabular revision surgery with a constrained polyethylene liner, she experienced multiple instances of instability consistent with anterior dislocation, as well as severe pain that required emergency care.
In 2010, Susan Simon had her left hip replaced using Smith & Nephew’s R3 acetabular system with an optional metal liner. According to court documents, Simon began experiencing “clicking, locking and radiating pain,” and X-rays later suggested her hip device had been improperly implanted. Simon underwent revision surgery in 2013, and in the same year she sued Smith & Nephew for negligence, defective design and breach of implied warranty. However, Judge Paul A. Engelmayer of the Southern District of New York dismissed the suit on December 3, 2013, and the court denied a motion to reconsider in March 2014.
In late 2012, a separate product liability lawsuit was filed by Jana Goldin against Smith & Nephew. In her complaint, Goldin alleged that as a result of her hip R3 acetabular revision surgery with a constrained polyethylene liner, she experienced multiple instances of instability consistent with anterior dislocation, as well as severe pain that required emergency care. Smith & Nephew filed multiple motions to dismiss the suit. In April 2013, Judge J. Paul Oetken dismissed the case per the company’s motions.
Although the cases above were dismissed, each case should be considered based on the patient’s individual circumstances and device components used. If you have experienced unexpected pain, instability, revision surgery or other complications after receiving a Smith & Nephew hip implant device, you should consult an attorney to explore your legal options and to ensure your legal rights are protected.