Medical Device MDL & Recall Status: Smith & Nephew (BHR, SMF, Redapt, Bipolar)

Smith & Nephew is a global medical technology business with approximately 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 Billion. The following is the status of pending multidistrict litigation (MDL) and defective product recalls involving major Smith & Nephew:


2775 IN RE: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation
District of Maryland (Hon. Catherine C. Blake)

Plaintiffs in the BHR MDL have recently filed a master amended complaint in which they accuse Smith & Nephew of waiting to recall its metal-on-metal hip resurfacing prosthesis until 2015 despite being aware of the device’s unreasonably high risk of premature failure as early as 2007. In the amended pleading, plaintiffs allege Smith & Nephew misrepresented the safety of the BHR system to physicians and patients and violated premarket approval requirements by failing to report adverse events.

In April, the United States Judicial Panel on Multidistrict Litigation (JPML) created this MDL regarding the premature failure of the Smith & Nephew Birmingham Hip Resurfacing (BHR) System and R3 Acetabular System. The BHR was approved by the U.S. Food and Drug Administration (FDA) in May 2006 through its expedited Premarket Approval process for Class III medical devices, as one of the first metal-on-metal hip replacement systems on the market, designed relieve pain and improve hip joint function. Smith & Nephew has faced litigation involving its hip implants since 2010. The company later withdrew the BHR device from the U.S. market in June 2015 due to similar high failure rates, particularly in women and in patients with smaller hip joints.

The lawsuits consolidated into the MDL share factual questions concerning the design, manufacture, marketing or performance of Smith & Nephew’s BHR system, and allege that (i) they have suffered pain, adverse local tissue reaction, pseudotumors, bone and tissue necrosis, metallosis, or other symptoms, often necessitating revision surgery, (ii) the FDA approval of the BHR required Smith & Nephew to meet several post-marketing surveillance and reporting requirements that were designed to ensure that in real-world use, the hip replacement system was safe and effective, and (iii) the manufacturer has failed to do so, claiming that Smith & Nephew knew for years about reports of complications with Birmingham hip resurfacing, including revision surgeries and failures, yet failed to adequately inform the doctors or patients.

Recent Recalls

Smith & Nephew Modular SMF and Modular Redapt Femoral Hip Systems Recall

In November 2016, Smith & Nephew recalled its Modular SMF and Modular Redapt hip implants “due to a higher than anticipated complaint and adverse event trend” with the modular necks used in the devices. Smith & Nephew also recalled the corresponding hip stem components.

The Modular SMF and Modular Redapt Hip System was approved for sale in 2008 and 2012, fast tracked through the FDA’s 510(k) process. Both implants have a modular cobalt chrome neck pieces that fit into titanium coated metal stems. Orthopedic doctors use the SMF model for primary and revision hip surgery and the Redapt model for revision surgery alone. Implants affected by the recall include those shipped from October 2008 through 2016.

According to Smith and Nephew, the metal-related injuries caused by the SMF and Redapt hips continued to increase with time.The SMF and Redapt hip implants have titanium coatings and use cobalt-chromium neck stems. Cobalt-chromium hip implants have been shown to release cobalt and chromium ions into the body leading to metallosis. Smith & Nephew found “patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products.”

Smith & Nephew Tandem Bipolar Hip System Recall

On August 29, 2016, Smith & Nephew recalled certain batches of its Tandem Bipolar Hip System in the United States due to a retainer groove that is out of specifications that can cause the artificial hip joint to disassemble, usually within the first few weeks of surgery. This necessitates painful revision surgery to remove and replace the defective artificial joint and treat injuries caused by the implant failure. Smith & Nephew stated that the defect will be discovered before the device is implanted in most cases as surgeons will notice that the device did not assemble properly. All unused units have been recalled.

In other news, according to a new series of reports on the orthopedic soft tissue repair market in the United States, as more of the baby boomer generation reaches retirement, their need for soft tissue arthroscopic surgery increases. Soft tissue repair is required for wear and tear of tendons, ligaments and cartilage. Arthroscopic surgery is becoming the preferred method of treatment as it is less invasive and reduces recovery time.

The shoulder labrum repair segment exhibits the highest amount of growth due to the high prescription rate as a go-to procedure for biceps and shoulder pain. This combined with the popularization of active lifestyles has made the demand for orthopedic soft tissue repair increase. However, interest in other segments is increasing, such as knee and hip arthroscopy.

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