New GLOBAL UNITE Reverse Fracture Shoulder Implant from DePuy Synthes Addresses Unmet Needs in Complex Shoulder Fractures

New system designed to preserve joint function and stability and promote bone healing

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May 22, 2018, 08:35 ET

WARSAW, Ind., May 22, 2018 /PRNewswire/ -- DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of the GLOBAL UNITE Reverse Fracture Shoulder, an innovative implant solution for shoulder reconstruction following complex fractures in patients with a grossly deficient rotator cuff. The new system is designed to provide increased flexibility for securely reattaching the bone to the implant, which is important for healing and function, and allowing biological fixation to the stem of the implant with a porous coating to help deliver a consistent surgical outcome. This new offering adds to DePuy Synthes' commitment to innovative shoulder solutions that address the full continuum of shoulder disorders.

Shoulder fractures are the second most common fracture of the upper extremity, representing 10 percent of all fractures in those older than 65 years and are increasing in frequency as the elderly population grows.¹When patients with grossly deficient rotator cuffs suffer 3- or 4-part fractures in the upper arm bone (proximal humerus), it is often challenging to provide consistent treatment that helps healing and restores motion. Increasingly, surgeons are shifting to a reverse shoulder implant for more consistent and predictable outcomes for these patients.²

"I find that especially in my older patients whose bone quality doesn't allow me to use the plates and screws typically used in a shoulder fracture procedure, fixation is an issue often due to weak rotator cuffs," said Dr. Carl Basamania***, Orthopaedic Surgeon. "In my experience with the GLOBAL UNITE Reverse Fracture Shoulder System I get strong fixation and I feel a lot more confident about moving patients early so they get better motion and a quicker return to function."

In a reverse total shoulder replacement, the ball and socket anatomy is reversed. A metal ball is fixed to the shoulder socket and a cup is fixed to the upper end of the humerus. Instead of using the rotator cuff to power the shoulder, the implant uses the deltoid muscle, which is the muscle at the top of the arm and shoulder.

The GLOBAL UNITE Reverse Fracture Shoulder provides:

Numerous suture holes, designed in the collar on top of the implant, and suture pockets around the backside of the implant to enhance bone fixation around the implant.
POROCOAT Porous Coating, a proprietary technology that consists of microscopic titanium beads. The porous structure supports biological fixation at the bone-implant interface.³
Backside pockets specially designed for bone graft, which may help promote bone growth and healing.
A streamlined instrumentation kit that is designed to improve cross compatibility across DePuy Synthes' shoulder offerings.

"DePuy Synthes' broad portfolio of shoulder solutions helps surgeons address a wide range of conditions from traumatic shoulder fractures to rotator cuff tears and instability," said Stephanie Chamberlain, Global Platform Leader Mitek Sports Medicine and Shoulder. "We offer solutions for minimally invasive surgery and complete shoulder reconstruction, all designed to restore mobility for patients."

The GLOBAL UNITE Reverse Fracture Shoulder is the latest implant offering under our GLOBAL UNITE Platform Shoulder System and builds on the company's long history in innovative shoulder reconstruction. This includes the DELTA XTEND Reverse Shoulder System and most recently the launch of TRUMATCH Personalized Solutions Shoulder System pre-surgical planning software for shoulder reconstruction, which can be used in both reverse and anatomic total shoulder arthroplasty to optimize implant positioning and placement.

The GLOBAL UNITE Reverse Fracture Shoulder will launch in the U.S. beginning in the 2018 second quarter. For more information click here.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional solutions and specialty surgery with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics 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.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and DePuy Orthopaedics, Inc.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.

***Dr. Carl Basamania is a consultant to DePuy Synthes Joint Reconstruction.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements," as defined in the Private Securities Litigation Reform Act of 1995, regarding the roll out of the GLOBAL UNITE™ Reverse Fracture Epiphysis (FX) Shoulder System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹Stanbury, SJ, Voloshin, I. Reverse Shoulder Arthroplasty for Acute Proximal Humeral Fractures in the Geriatric Patient Geriatr Orthop Surg Rehabil. 2011 Sep-Nov; 2(5-6): 181–186.

²Gallinet D, et al. Improvement in shoulder rotation in complex shoulder fractures treated by reverse shoulder arthroplasty. J Shoulder Elbow Surg (2013) 22, 38-44.

³Karageorgiou V, et al. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials 2005;26:5474-91.

SOURCE DePuy Synthes