DePuy Synthes Launches Radial Head Replacement System with Radiolucent Trials to Improve Visualization and Sizing

Side Loading Spacers and Single-Use Instrument Kits Further Enhance Surgical Efficiency and Reduce Costs

WEST CHESTER, PA – October 21, 2020 – The Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes has launched its Radial Head Replacement System in the United States, further expanding its offering in extremities. The Radial Head Replacement System is used with patients who have experienced destabilizing radial head fractures that cannot be repaired. The Radial Head Replacement System is also useful in the elective management of elbow arthritis.

Radial head fractures account for 33% of all elbow injuries and can reduce the quality of life for patients.^1,2 Inaccurate sizing of the implant during surgery due to visualization challenges³ can lead to complications such as decreased range of motion, elbow stiffness, bone erosion and elbow and/or wrist pain, both post-operatively and long term. Undersizing a radial head implant may fail to stabilize the elbow properly. Oversizing, also known as overstuffing, of the implant may lead to altered joint movement and excessive load on the radiocapitellar joint.⁴ Overstuffing is one of the most common clinical complications and has been shown to occur in 23% of surgeries.^5-8

The DePuy Synthes Radial Head Replacement System is the first system to provide Radiolucent Trials to help promote accurate sizing by allowing for direct and radiographic visualization of the elbow joint during trialing.⁹ In addition, the Radiolucent Trials utilize side-loading Spacers to allow surgeons to determine implant height without repeated removal of trial stems.

The DePuy Synthes Radial Head Replacement System also offers smooth stemmed implants, which are designed to allow for unrestricted motion, allowing the stem to self-center inside the radial canal.^9-10 Current literature and clinical experience suggest straight, smooth stemmed implants are associated with lower incidence of symptomatic implant loosening than press-fit implants.^5,6,11-17

“I believe DePuy Synthes Radial Head Replacement System has one of the most accurate sizing systems on the market,” said Dr. Michael Wiater**, Orthopaedic Surgeon specializing in Shoulder and Elbow surgery, Royal Oak, Michigan. “In addition, the single-use packaging decreases inventory and saves time in the OR.”

The DePuy Synthes Radial Head Replacement System is available in compact, sterile, single-use instrument kits, helping to improve efficiency, reduce costs and minimize surgical delays.^18-22 This may translate to less time spent pre-operatively searching for equipment.^19,23-25

“We are pleased to integrate this technology into our portfolio alongside our current offerings and provide comprehensive solutions for the treatment of fractures and conditions in the extremities,” said I.V. Hall***, Worldwide President, Trauma, Extremities, CMF and Animal Health, DePuy Synthes. “This launch allows us to bring a differentiated solution to surgeons treating the common injury of radial head fractures, while also providing greater efficiency and reducing costs.”

The DePuy Synthes Radial Head replacement is being showcased at the 2020 Orthopaedic Trauma Association Virtual Annual Meeting as part of DePuy Synthes’ innovative solutions that address unmet needs for surgeons and patients in traumatic injuries to extremities.

About Johnson & Johnson Medical Devices Companies

At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.jnjmedicaldevices.com.

*Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
**Dr. Wiater is a paid consultant to DePuy Synthes
***I.V. Hall is an employee of Medical Device Business Services, Inc.

1. Pappas N, Berstein J. Radial Head Fractures. Association of Bone and Joint Surgeons. 2009
2. Pike JM, Athwal GS, Faber KJ, King GJ. Radial head fractures: an update. J Hand Surg Am. 2009;34:557–565.
3. DePuy Synthes Report: See Better Size Better Memo. 2019. Ref: 0000290188.
4. Van Glabbeek F, Van Riet RP, Baumfeld JA, Neale PG, O’Driscoll SW, Morrey BF, An KN (2004) Detrimental effects of overstuffing or understuffing with a radial head replacement in the medial collateral-ligament deficient elbow. J Bone Join surg Am 86-A(12):2629-2635
5. Grewal, R., J. MacDermid, K. Faber, D. Drosdowech and G. King (2006). “Comminuted radial head fractures treated with a modular metallic radial head arthroplasty. Study of outcomes.” The Journal of Bone and Joint surgery. American volume 88(10): 2192.
6. Doornberg, J., R. Parisien, P. van Duijn and D. Ring (2007). “Radial head arthroplasty with a modular metal spacer to treat acute traumatic elbow instability.” The Journal of Bone and Joint Surgery. American volume 89(5): 1075.
7. Chien, H., A. Chen, J. Huang, C. Cheng and K. Hsu (2010). “Short-to medium-term outcomes of radial head replacement arthroplasty in posttraumatic unstable elbows: 20 to 70 months follow-up.” Chang Gung Medical Journal 33(6): 668.
8. Rodriguez-Quintana, D., D. Comulada, N. Rodriguez-Quintana and F. Lopez-Gonzalez (2017). “Radial Head Ingrowth Anatomic Implant Versus Smooth Stem Monoblock Implant in Acute Terrible Triad Injury: A Prospective Comparative Study.” Journal of Orthopaedic Trauma 31(9): 503.
9. Acevedo, D., E. Paxton, I. Kukelyansky, J. Abboud and M. Ramsey (2014). “Radial head arthroplasty: state of the art.” The Journal of the American Academy of Orthopaedic Surgeons 22(10): 633.
10. Szmit J, King GJ, Johnson JA, Langohr DG. The effect of stem fit on the radiocapitellar contact mechanics of a metallic axisymmetric radial head hemiarthroplasty: is loose fit better than rigidly fixed? J Shoulder Elbow Surg. 2019;28:2394-2399.
11. DePuy Synthes Report: Radial Head Replacement Literature Review Memo.2019. Ref: 0000292472
12. Flinkkilä, T., T. Kaisto, K. Sirniö, P. Hyvönen and J. Leppilahti (2012). “Short-to mid-term results of metallic press-fit radial head arthroplasty in unstable injuries of the elbow.” The Journal of Bone and Joint Surgery. British volume 94(6): 805.
13. Allavena, C., S. Delclaux, N. Bonnevialle, M. Rongières, P. Bonnevialle and P. Mansat (2014). “Outcomes of bipolar radial head prosthesis to treat complex radial head fractures in 22 patients with a mean follow-up of 50 months.” Orthopaedics & Traumatology, Surgery & Research: OTSR 100(7): 703.
14. Nestorson, J., P.-O. Josefsson and L. Adolfsson (2017). “A radial head prosthesis appears to be unnecessary in Mason-IV fracture dislocation.” Acta Orthopaedica 88(3): 315.
15. Duckworth, A. D., N. R. Wickramasinghe, N. D. Clement, C. M. Court-Brown and M. M. McQueen (2014). “Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal?” Clin Orthop Relat Res 472(7): 2136-2143.
16. Moghaddam, A., T. F. Raven, E. Dremel, S. Studier-Fischer, P. A. Grutzner and B. Biglari (2016). “Outcome of radial head arthroplasty in comminuted radial head fractures: short and midterm results.” Trauma Monthly 21(1).
17. Katthagen, J. C., G. Jensen, H. Lill and C. Voigt (2013). “Monobloc radial head prostheses in complex elbow injuries: results after primary and secondary implantation.” International Orthopaedics 37(4): 631.
18. R. D. Shippert, “A study of time-dependent operating room fees and how to save $100,000 by using time-saving products,” American Journal of Cosmetic Surgery, vol 22, no. 1, pp. 25-34, 2005.
19. Traverso LW, Hargrave K. A prospective cost analysis of laparoscopic cholecystectomy. Am J Surg. 1995; 169;503-506.
20. Anwar F, Shoaib RF. Critical incident identification in common orthopaedic injury. JPMA. The Journal of the Pakistan Medical Association. 2009;59(2):71-74
21. McCormack J. Satisfy surgeons by improving instrument turnaround time. Materials management in health care. 1995;4(8):18,20
22. Harden JL, Hiscox JA. Cost savings and quality improvement–single use suture instruments? Scottish Medical Journal. 2006;51(3):30-33.
23. DePuy Synthes Report: Complete Compact Efficient Memo.2019.Ref: 0000290469.
24. Ford, S. “Nurses waste ‘an hour a shift’ finding equipment,” Nursing Times. 105(5):1, 2009 February
25. Wong J, Khu KJ, Kaderali Z, Bernstein M. Delays in the operating room: signs of an imperfect system. Canadian Journal of Surgery. 2010; 53(3):189-195.

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CONTACT: Meghan Grimaldi
Mgrimal4@its.jnj.com