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Zimmer Biomet recalls comprehensive reverse shoulder.

A Class I recall was announced for the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray (Model 115340), following a determination that these devices are fracturing at a higher rate than stated in the labeling. Class I is the U.S. Food & Drug Administration's (FDA) most serious recall category, and indicates the products included in the Zimmer Biomet shoulder replacement recall may cause serious injuries or death.

"Individuals who experience a fracture of their Zimmer Biomet shoulder replacement may require revision surgery, which can result in permanent loss of shoulder function, infection and even death," said Sandy Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing patients harmed by recalled medical devices. The firm is now offering free legal reviews to individuals who suffered injuries and complications related to a Zimmer Biomet shoulder replacement fracture.

On Dec. 20, 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement regarding certain Comprehensive Reverse Shoulder Humeral Trays associated with a higher-than-anticipated rate of fracture. The notice affected 3,662 Comprehensive Reverse Shoulder Humeral Trays:

* Manufactured from Aug. 25, 2008, to Sept. 27, 2011

* Distributed from October 2008 to September 2015

* Product Codes: KWS, PAO

* All lots with part number 115340

On Feb. 16, the FDA designated Zimmer Biomet's notice a Class I recall. According to the agency, there are "no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow-up protocol."

The Zimmer Biomet Comprehensive

Reverse Shoulder is designed to restore arm movement in patients undergoing reverse shoulder replacement. The device is beneficial in patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement. The Comprehensive Reverse Shoulder was brought to market through the FDA's 510(k) program, which allows a medical device manufacturer to forgo human clinical trials if it demonstrates a product is "substantially equivalent" to another device previously approved by the agency.

Recipients of the Comprehensive Reverse Shoulder who experienced a fracture related to this recall may be entitled to compensation for pain and suffering.

AdvaMed Urges Device Tax Repeal

Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker has urged President Donald Trump to support a repeal of the 2.3 percent medical device tax.

"As the president outlines his plans to spur American job creation, we urge him to do one simple thing that will guarantee the growth of good-paying jobs in the U.S.--urge repeal of the medical device excise tax," Whitaker said before Trump addressed a joint session of Congress in late February.

"The medical technology industry is a uniquely American success story, responsible for nearly 2 million high-tech, high-pay jobs in communities large and small in every state," he continued.

"But the industry's potential for continued job creation and its ability to develop the next generation of life-changing advancements for patients is under threat by the continued existence of the medical device excise tax. While the current suspension of the tax is helpful, companies need the certainty of permanent repeal in order to invest long-term in R&D, capital improvements, and hiring."

"The president and Congress need to do the right thing and permanently repeal this onerous tax," Whitaker concluded.

Wenzel Spine Acquires Interspinous & Facet Fixation Product Platforms

Wenzel Spine Inc. has completed the acquisition of the PrimaLOK SP Interspinous Fusion System and PrimaLOK FF Facet Fixation System from OsteoMed LLC.

The PrimaLOK SP and FF platforms include a polyaxial interspinous process device and percutaneous facet screw system designed for minimally invasive surgery (MIS) applications in the treatment of lumbar spinal disorders. They are designed to provide surgeons an expanded MIS solution when used in conjunction with the stand-alone, expandable, Vari-Lift-LX interbody fusion device.

"This acquisition provides our distributors and surgeons a powerful combination of MIS solutions. When paired with our VariLift-LX stand-alone, expandable, interbody technology, surgeons now have the ability to provide supplemental fixation, when needed, without having to revert to pedicle screw constructs," said Chad Neely, president and CEO of Wenzel Spine. "In addition, this expands our current product portfolio while strengthening our development pipeline and demonstrating our commitment to the development of MIS solutions to our distribution and surgeon partners."

Dr. Charles Gordon, inventor of the PrimaLOK SP System and founder of the Texas Spine & Joint Hospital, commented, "I am pleased that Wenzel Spine has added the PrimaLOK Systems to their product portfolio. We are very happy to be partnered with a spine-focused company and believe Wenzel Spine is the ideal partner to bring the full potential of the PrimaLOK Systems to market. There are tremendous MIS opportunities in combining the advantages of the PrimaLOK and VariLift-LX technologies."

Wenzel Spine plans to integrate the PrimaLOK platforms into the pipeline of MIS solutions currently being developed. The company completed a limited U.S. release of the PrimaLOK SP and FF Systems and expects to offer wide U.S. release in the second quarter of 2017.

Excellent Clinical Outcomes for Medial-Pivot Knee System at 17 Years

MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting-edge joint replacement implants designed to help patients achieve full function faster, announced that The Knee published a study evaluating long-term clinical and radiographic outcomes of the Medial-Pivot Knee System. The results demonstrate excellent clinical outcomes for both satisfaction (95 percent) and survivorship (98.8 percent) at 17 years with patients noting a great sense of stability and comfort during regular activities. (1)

It was reported that approximately 20 percent of patients are not satisfied with the outcome of their total knee replacement due to residual pain and functional issues often attributed to implant design. (2) MicroPort's Medial-Pivot Knee System is designed to restore stability and normal knee kinematics to deliver reproducible outcomes that can improve function and drive patient satisfaction.

"I am in my third year of using the Evolution Medial-Pivot Knee System and this publication validates the results that I have seen in my practice," said David Backstein, M.D., MEd, F.R.C.S.C, head of orthopedic surgery at Mount Sinai Hospital in Toronto, Ontario. "In my experience, the functional outcomes for patients treated with this system have certainly been superior than the systems I've used in the past and patients have fewer complaints. When I see them at six or eight weeks follow-up, they're at a different stage of recovery than I was seeing previously with traditional implant designs. I've been exceptionally happy with the results and feel comfortable knowing I am implanting a prosthesis with 98.8 percent survivorship at 17 years."

The paper, titled, "A Long Term Clinical Outcome of the Medial Pivot Knee Arthroplasty System," was authored by George Macheras et al. from the "KAT" General Hospital, Athens, Greece. In the study, 325 patients with knee osteoarthritis underwent total knee arthroplasty using the Medial-Pivot prosthesis. Al patients showed a statistically significant improvement in the Knee Society clinical rating system, Western Ontario and Mc-Master Universities Osteoarthritis Index, and Oxford knee score. Ninety-four percent of patients were able to perform age-appropriate activities with average knee flexion of 120 degrees and 98 percent of patients reported pain relief to be excellent, very good, or good. Survival analysis showed a cumulative success rate of 98.8 percent at 17 years.


(1) George A. Macheras et al. "A long term clinical outcome of the Medial Pivot Knee Arthroplasty System."The Knee Journal, Published: January 29, 2017.

(2) Thambiah, Matthew Dhanaraj et al. "Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective."Singapore Medical Journal 56.5 (2015): 259-263. PMC. Web. 22 Feb. 2017.

Paragon 28 Launches Reconstruction System and Hammertoe Allograft System

Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched products and instrumentation that help streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefiting both the surgeon and patient.

The company's Gorilla Medial Column Plating System offers surgeons 36 plating options to address varying patient anatomies and levels of deformity and includes plates of varying thickness (1.5 and 2 mm) to account for size and condition severity. The plates are constructed from titanium (Ti6AI4V-ELI) for increased strength. All plates accept 2.7-, 3.5-, and 4.2-mm locking and non-locking polyaxial screws allowing the surgeon to target the highest quality bone around the fracture site. All plates accept both R3CON and TuffNeck screw technologies, allowing surgeons flexibility to vary the stoutness of the construct. Additionally, all holes have a built-in recess to reduce screw head prominence.

The plate features superior holes on the arch and proximal arch plates that are tabbed, allowing the surgeon to bend the plate to better contour to the talus. It also features fixed axis screw trajectories intended to capture the highest quality bone on either side of each fusion site without intersecting. This system includes procedure-specific instrumentation to facilitate dissection and accurate plate placement.

A pin distractor allows for greater exposure to joint spaces to aid in removal of osteophytes and cartilage. A compression-distraction device attaches on either side of the plate or bone fusion site using two K-wires to create in-line compression or distraction. A subchondral drill is included for use in arthrodesis joint preparation; the instrument provides approximately 10 mm of controlled drilling of subchondral bone with a stop to help prevent deeper penetration. Finally, a cartilage removal tool provides "reverse cutting" functionality which is ideal for debridement of curved, small and/or difficult to access joints.

Dr. Chris Coetzee, M.D., helped design the plates included in this system.

Paragon 28 also added to its PRESERVE line of allograft solutions with the launch of the PRESERVE HammerGraft System.

Paragon executives claim the PRESERVE line is unique because all implants are aseptically processed (free of gamma radiation and bleaching). Competitive implants which are gamma radiated have demonstrated greater structural fatigue when compared to non-gamma radiated allograft. The use of bleaching has been shown to reduce the osteoinductivity of the graft and may substantially increase the time needed for incorporation.

The HammerGraft System provides four allograft implants in 2.3 and 2.8 mm straight and angled options, according to the company. These grafts are harvested from the cortical rim of the tibia or femur to match the density of the PIP joint and ensure strength and blood flow requirements of the region are met. Ribs on the graft in conjunction with the drill diameter were sized to minimize crushing of cancellous bone and optimized to resist pull-out of the implant following insertion. The cross section of the implant helps to resist rotation and tapered ends ease insertion. The HammerGraft implant is packaged in a hydration solution and may be used immediately out of the packaging (no reconstitution required).

The system also includes the market's first dense cancellous spacers, which are available in 6-, 8-, and 10-mm sizing options. These spacers are designed to fit over the HammerGraft and may be used in cases where lengthening is needed at the PIP joint.

Synergy Biomedical Awarded CE Mark for BioSphere Putty

Synergy Biomedical LLC, a developer of bone graft products for spine and orthopedic surgery, has received CE mark clearance in the European Union for its next-generation bone graft, BioSphere Putty.

Originally launched in the United States in 2013, BioSphere Putty is a synthetic bone graft product that uses a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the company's patented BioSphere Technology, BioSphere Putty has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range.

"Since its introduction, BioSphere Putty has been very well-received by surgeons due to its successful clinical use and excellent intraoperative handling," said Dr. Mark Borden, Ph.D., president/CEO of Synergy. "We are very pleased to receive our CE Mark and are looking forward to introducing a truly next-generation, synthetic bone graft product to the European community."

Under its cleared European indication, BioSphere Putty is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with auto-graft or allograft.

"When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BioSphere Putty is an elegant bone graft solution that is based on scientifically valid principles," said Erik Westerlund M.D., F.A.C.S., director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in Columbus, Ga. "It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone in growth. My clinical experience with BioSphere Putty over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution."

Biosphere Putty is the first of several bone graft products being developed by Synergy Biomedical that use patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BioSphere Putty provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. The Putty is touted as having the highest bioactive glass composition on the market.

Based in Collegeville, Pa., Synergy Biomedical is a privately-held developer of biomaterial-based products for the orthopedic and spinal surgery markets. The company was founded in 2011.
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Title Annotation:NEWS FRONT
Publication:Orthopedic Design & Technology
Date:Mar 1, 2017
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