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Smith+Nephew Launches OR3O™ Dual Mobility System in Japan for Use in Primary and Revision Hip Arthroplasty

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Features exclusive OXINIUM™ DH material; removes Cobalt Chromium alloy reducing the risk of wear and corrosion1

LONDON, September 20, 2022 /PRNewswire/ — Smith+Nephew (LSE: SN, NYSE: SNN), the global medical technology company, today announces the launch of its OR3O Dual Mobility System for use in primary and hip replacement surgeries. revision in Japan. Compared to traditional solutions, dual mobility implants have a small diameter femoral head that locks into a larger polyethylene insert – increasing stability, reducing the risk of dislocation and providing a better range of motion.2




Smith+Nephew OR3O Dual Mobility Hip System

While most competitive devices use a cobalt chrome (CoCr) coating with CoCr or ceramic head balls, OR3O incorporates Smith+Nephew’s latest advanced bearing surface, OXINIUM DH, for its coating and proprietary OXINIUM on XLPE for its femoral head and its polyethylene inserts. This eliminates both the modular CoCr liner and/or the CoCr spherical head from the construction, reducing the risk of wear and corrosion that has been associated with the alloy.1

OXINIUM DH (Diffusion Hardened) is a unique variation of Smith+Nephew’s OXINIUM technology platform that increases hardening depth through an additive manufacturing process.

The modular dual mobility segment was introduced to Japan in 2013 and continued to grow globally. Postoperative dislocation is the second most common reason for revision of a total hip replacement worldwide3-6 and remains a major concern for surgeons when performing total hip replacement surgery. Studies have shown that dual mobility is ideally positioned to manage dislocation better than large head metal-on-metal or ceramic-on-ceramic series.seven

“Smith+Nephew’s OR3O Dual Mobility System is a revolutionary introduction to Japan which offers technology not available in competing systems,” said Shinya DobashiFirst Vice-President and General Manager, North Asia, Smith+Nephew. “More than a dozen peer-reviewed publications have now cited or expressed concerns about corrosion or high ions in modular CoCr dual mobility coatings.8-20 Reduced corrosion1 of our OXINIUM and OXINIUM DH bearing surfaces sets OR3O apart from the competition.”

Smith+Nephew’s OR3O™ Dual Mobility System is available in Japan for primary and revision applications and offers cross compatibility with the R3™ Acetabular System.

References

  1. Parikh A; Pawar V; Sprague J. Long-term Simulator Wear Performance of an Advanced Bearing Technology for THA. Poster presented at the ORS. 2013; Poster No.: 1028
  2. Darrith B, Courtney PM, Della Valle Chief Justice. Results of dual mobility components in total hip arthroplasty. Bone Joint J 2018;100-B:11–19.
  3. Australian Orthopedic Association National Joint Replacement Register (AOANJRR). Hip, Knee and Shoulder Arthroplasty: 2021: 2021 Annual Report, Adelaide; AOA, 2021: [Available at: https://aoanjrr.sahmri.com/annual-reports-2021 ]
  4. Joint National Register of England, Wales and North Ireland18th annual report [Available at: https://reports.njrcentre.org.uk/downloads ]
  5. American Joint Replacement Registry (AJRR), The Seventh Annual AJRR Report on Hip and Knee Replacement Surgery 2021, American Academy of Orthopedic Surgeons
  6. Italian Arthroplasty Register, Addendum to Annual Report 2019, English version of tables and figures, October 2020
  7. Boyer, B., Philippot, R., Geringer, J. & Farizon, F. (2011). “Primary total hip prosthesis with dual mobility socket to prevent dislocation: a 22-year follow-up of 240 hips”, International Orthopedics (SICOT) (2012) 36: 511-518
  8. Spece, H., MacDonald, DW, Mont, MA, Lee, G.-C. and Kurtz, SM, “Fretting Corrosion and Polyethylene Damage Mechanisms in Modular Dual Mobility Total Hip Arthroplasty,” Beyond the Implant: Retrieval Analysis Methods for Implant Monitoring, ASTM STP1606
  9. Nam, D., Salih, R., Nahhas, C., Barrack, R. & Nunley,R, (2019). “Is a dual mobility modular cup a viable option for the active young patient who has undergone total hip replacement surgery?” », Bone Joint J 2019; 101-B: 365–371
  10. Matsen Ko, L., Pollag, K., Yoo, J. & Sharkey, P (2015). “Serum metal ion levels after total hip arthroplasty with dual modular mobility components,” The Journal of Arthroplasty 31 (2016) 186–189
  11. Civinini, R., Cozzi Lepri, A., Carulli, C., Matassi, F., Villano, M., & Innocenti, M. (2019). “Patients after revision total hip arthroplasty with modular dual mobility components and an internal cobalt-chromium metal head are at risk for increased serum metal ion levels,” The Journal of Arthroplasty 35 (2020 ) S294eS298
  12. Romero, J., Wach, A., Silberberg, S., Chiu, Y., Westrich, G., Wright, T. and Padgett, D. (2020) ‘2020 Otto Aufranc Award: Malseating of modular dual mobility liners; Impact and Implications’, Bone Joint J 2020; 102-B (7 Supplement B): 20–26
  13. Lee, G., Kamath, A. & Maxwell Courtney, P. (2020). ‘Clinical concerns with dual mobility – Should I avoid it when possible?’, Article in press, The Journal of Arthroplasty xxx (2021) 1e4
  14. Gkiatas, I., Sharma, A., Greenberg, A., Duncan, S., Chalmers, B. & Sculco, P. (2020). “Serum Metal Ion Levels in Dual Mobility Modular Acetabular Components: A Systematic Review,” Journal of Orthopedics 21 (2020) 432–437
  15. Steven M. Kurtz et al. (2015) “Is There Material Loss at the Backside Taper in Modular CoCr Acetabular Liners?” ”, Clinical Orthopedics and Related Research, 473: 275–285
  16. Lombardo, D., Siljander, M., Gehrke, C., Moore, D., Karadsheh, M. & Baker, E. (2018). ‘Fretting and Corrosion Damage of Retrieved Dual-Mobility TotalHip Arthroplasty Systems’, The Journal of Arthroplasty 34 (2019) 1273e1278
  17. Kolz, J., Wyles, C., Van Citters, D., Chapman, R., Trousdale, R. & Berry, D. (2020). ‘In vivo corrosion of dual mobility modular implants: a salvage study’, The Journal of Arthroplasty 35 (2020) 3326e3329
  18. Sonn, K. & Meneghini, R. (2020). “Case Report: Adverse Local Tissue Reaction Due to Acetabular Corrosion in Dual Mobility Modular Constructs”, Arthroplasty Today 6 (2020) 976e980
  19. Tarity, T., Koch, C., Burket, J., Wright, T. & Westrich, G. (2016). ‘Fretting and Corrosion at the Backside of Modular Cobalt Chromium Acetabular Inserts: A Retrieval Analysis’, The Journal of Arthroplasty 32 (2017) 1033e1039
  20. DC Markel, T. Bou-Akl, MD Rossi, N. Pizzimenti, B. Wu, W. Ren (2019). “Blood Metal Levels, Leukocyte Profiles, and Cytokine Profiles in Patients with Modular Dual Mobility Hip Prosthesis: First Results from a Prospective Cohort Study,” Bone Joint J 2019; 101-B: 1035–1041

About Smith+Neveu
Smith+Nephew is a portfolio medical technology company focused on hard and soft tissue repair, regeneration and replacement. We exist to restore people’s bodies and their self-confidence by using technology to push the limits of life. We call this goal ‘Life Unlimited’. Our 18,000 employees carry out this mission every day, making a difference in the lives of patients through the excellence of our product portfolio, as well as the invention and application of new technologies in our three global orthopedics, sports and ENT medicine and advanced wound management franchises.

Founded in Hull, United Kingdomin 1856, we now operate in over 100 countries and generate annual sales of $5.2 billion in 2021. Smith+Nephew is part of the FTSE100 (LSE:SN, NYSE:SNN). The terms “Group” and “Smith+Nephew” are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context otherwise requires.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, instagram Where Facebook.

Forward-looking statements
This document may contain forward-looking statements which may or may not prove to be accurate. For example, statements regarding expected revenue and trading margin growth, market trends and our product portfolio are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well placed”, “believe”, “estimate”, “expect”, “target”, “consider ” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: risks related to the impact of COVID-19, such as the magnitude and duration of its impact, government actions and other restrictive measures taken in response, significant delays and cancellations elective procedures, reduced procedural capacity at medical facilities, restricted access of sales representatives to medical facilities, or our ability to execute business continuity plans due to COVID-19; economic and financial conditions in the markets we serve, particularly those affecting healthcare providers, payers and customers (including, without limitation, as a result of COVID-19); price levels of established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other governmental actions; product defects or recalls or other issues with quality management systems or non-compliance with related regulations; disputes relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers (including without limitation as a result of COVID-19); competitions for qualified personnel; strategic actions, including acquisitions and divestitures, our success in performing due diligence, evaluation and integration of acquired businesses; disruptions that may result from transactions or other changes we make to our business plans or organization to adapt to market changes; and many other matters that affect us or our markets, including those of a political, economic, commercial, competitive or reputational nature. Please refer to the documents Smith+Nephew has filed with the United States Securities and Exchange Commission under the United States Securities Exchange Act of 1934, as amended, including Smith+Nephew’s latest annual report on Form 20-F, for a discussion of some of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this cautionary statement. Smith+Nephew undertakes no obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew’s expectations.

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