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Medical Device MDL & Recall Status: Smith & Nephew

Medical Device MDL & Recall Status: Smith & Nephew

For more information, please contact The Ahearne Law Firm, PLLC for an initial consultation and case evaluation. Call nationwide at (845) 986-2777.

The following is the status of pending multidistrict litigation (MDL) and defective product recalls involving major orthopedic medical device manufacturer, Smith & Nephew:

MDL

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

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.

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.

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.

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If you or a family member have suffered injury from an orthopedic medical device manufactured by Smith & Nephew, you and/or your family member may be entitled to money damages.

For more information, please contact The Ahearne Law Firm, PLLC for an initial consultation and case evaluation. Call nationwide at (845) 986-2777.

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