Smith & Nephew, PLC, is a global medical device manufacturer founded over 160 years ago in the United Kingdom, where it is still headquartered to this day. Smith & Nephew is a leading player in the global market for orthopedic reconstruction, competing with the likes of DePuy Synthes, Zimmer, Biomet, and Stryker for dominance in the hip and knee implant categories.
One of Smith & Nephew’s more well-known product lines is its Birmingham Hip Resurfacing System (BHR) which has been used in more than 190,000 procedures worldwide. In 2017, the metal-on-metal (MoM) BHR system became the focus of multidistrict litigation (MDL) in Maryland alleging defects in the BHR and the R3 hip joint. Both were the subject of recalls in 2006, 2012, and 2015 due to high rates of failure and revision surgeries as well as issues with erosion and metallosis. Additionally, patients implanted with the BHR and R3 claim that Smith & Nephew knew of common MoM issues with their products but either underreported them to the FDA or did not report them properly at all.
History and Background of Smith & Nephew
Established as a family-owned pharmaceutical enterprise in Hull, England, in 1856, Smith & Nephew was founded by Thomas James Smith and later helmed by his nephew, Horatio Nelson Smith. The firm first came to prominence during the first world war when it was contracted by the French Army to supply surgical and field dressings.
Today, Smith & Nephew is a global healthcare conglomerate focused on wound management, endoscopy, and orthopedics. In 2019, the company reported total revenue of $5.138 billion, the bulk of which came from orthopedic device sales – such as hip and knee implants. It has over 17,500 employees and operates in over 100 countries. In recent years, as part of an apparent bid at expansion in the lucrative U.S. orthopedic device market, Smith & Nephew acquired at least two large companies specializing in robotics-assisted surgery.
Smith & Nephew first implanted its BHR Hip Resurfacing system in 1997 and it was subsequently approved for use by the U.S. Food and Drug Administration (FDA) in 2006. Smith & Nephew claims that the design of its BHR system is intended to decrease the risk of dislocation and is particularly well-suited to “young, active male patients”.
Issues with Smith & Nephew Hip Implant Technologies and Implant Lines
At the center of the BHR device is a metal femoral head that is combined with a metal acetabular cup to form a “Metal on Metal” (MoM) implant. The BHR is a prosthesis and it is comprised of two main components:
- The Birmingham Resurfacing Femoral Head; and
- The Birmingham Resurfacing Acetabular Cup.
The FDA order allowing Smith & Nephew to market the BHR in the United States required the company to comply with several post-market survey and reporting practices relaying knowledge of adverse reactions, injuries or issues with the device, back to the FDA.
According to claims filed by patients implanted with the BHR system components, it can fail prematurely while causing pseudotumors and metallosis. Claimants in litigation pending before a Maryland federal court allege that Smith & Nephew in fact knew about a multitude of common MoM issues and adverse reports involving the BHR but either delayed reporting them to the FDA, underreported them, or did not report them properly at all.
Sources Cited (13)
1. “Our History” https://www.smith-nephew.com/about-us/who-we-are/our-history/
2. “At a Glance” https://www.smith-nephew.com/about-us/who-we-are/at-a-glance/
3. “Fifteen Things to Know About Smith & Nephew” https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/26047-15-things-to-know-about-smith-nephew.html
4. “Annual Report 2019” https://www.smith-nephew.com/annual-report-20191/
5. “Minnesota Man Blames Smith & Nephew for Hip-Implant Failure” https://newyork.legalexaminer.com/health/minnesota-man-blames-smith-nephew-for-hip-implant-failure/
6. “Birmingham Hip” https://www.smith-nephew.com/professional/products/all-products/bhr-birmingham-hip-resurfacing/
7. “Why Do Smith & Nephew Birmingham Hips Fail?” https://fortworth.legalexaminer.com/health/smith-nephew-birmingham-hips/
8. “Hip Resurfacing” https://www.hss.edu/condition-list_hip-resurfacing.asp
9. “Metal-on-Metal Hip Implants” https://www.fda.gov/medical-devices/implants-and-prosthetics/metal-metal-hip-implants
10. “Metal-on-Metal Hip Arthroplasty: A Review of Adverse Reactions and Patient Management” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598667/
11. “Hip Revision” https://my.clevelandclinic.org/health/treatments/17104-hip-revision#:~:text=Hip%20revision%20surgery%20is%20performed,hip%20can%20function%20normally%20again.
12. “Metallosis: A diagnosis not only in patients with metal-on-metal prostheses” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750564/
13. “Concerns about Metal-on-Metal Hip Implants” https://www.fda.gov/medical-devices/metal-metal-hip-implants/concerns-about-metal-metal-hip-implants
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
