Safe Orthopaedics: Half-year 2016 results

September 27, 2016 – ERAGNY-SUR-OISE, France–(BUSINESS WIRE)

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments has announced its half-year 2016 results for the six months to June 30, 2016, as approved by the Board of Directors on September 27, 2016.

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, said: “In parallel with the implementation of our new strategy of refocusing on regions growing most rapidly, we introduced a cost-cutting policy in the first six months of 2016, which will deliver greater benefits starting in the second half of 2016. We are also continuing our international expansion drive. We moved into new territories and are working hard to raise the visibility of our products in the scientific community, so that the use of single-use instruments for back surgeries gains further traction.”

in thousands of euros H1 2016 H1 2015
Adjusted revenue* 1,204 1,045
Revenue 1,303 1,307
Purchases used and change in inventories (981) (894)
External costs (1,362) (1,141)
Personnel costs (2,010) (1,983)
Other operating expenses (351) (308)
Operating income/(loss) before non-recurring items (3,402) (3,019)
Operating income/(loss) (3,412) (3,019)
Net financial income/(expense) (158) 301
Net income/(loss) (3,559) (2,727)

Adjusted first-half 2016 revenue up 15%

Following the introduction of the new strategy unveiled by Safe Orthopaedics in March of refocusing on its fastest-growing regions, it recorded adjusted revenue of €1.2 million in the first half of 2016. This represented an increase of 15%, with balanced contributions from France and the Rest of the World. Including the contribution of €0.26 million from the United States in the first half of 2015, total revenue was stable at €1.3 million compared with the year-earlier period.

Safe Orthopaedics has consolidated its sales performance in France and achieved major progress in the Rest of the World.

In parallel, Safe Orthopaedics continued to expand its international distribution network by entering into additional agreements covering Australia, New Zealand and two initial countries in Latin America (Chile and Mexico). Further territories are also expected to be added during the second half of the year.

Launch of a drive to cut operating costs

Safe Orthopaedics’ first-half 2016 operating loss came to €3.4 million, compared with a loss of €3.0 million in the same period of 2015. This increase included €0.4 million in non-recurring expenses incurred as a result of refocusing in France and the Rest of the World and the departure in June of the previous Chief Executive Officer.

After taking into account €0.16 million in net financial expense as a result of currency effects on intragroup cash balances, Safe Orthopaedics recorded a first-half 2016 net loss of €3.6 million, compared with a loss of €2.7 million in the first six months of 2015.

During the period, Safe Orthopaedics launched a cost-cutting policy, which should start to pay off from the second half of 2016.

Stronger cash position

At June 30, 2016, Safe Orthopaedics held €4.3 million in cash. This does not include a €0.5 million subscription by IdInvest Partners in early July following the Shareholders’ Meeting on June 30, 2016 and another €0.5 million subscription raised from IdInvest Partners in the form of OCABSA bonds on July 26, 2016.

Next Press Release: Q3 2016 revenue, October 13, 2016 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the SteriSpine™ Kits are CE-marked and FDA cleared. The company is based at Eragny-sur-Oise (France), and has 34 employees. For more information, visit:www.SafeOrtho.com

* Adjusted for operations in the United States discontinued effective March 1, 2016.

Contacts

Safe Orthopaedics
Thierry Lambert, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
or
Nicolas Merigeau
Media Relations
Tel. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Amendia Launches New SYZYGY™ Spine Stabilization System

MARIETTA, GA (PRWEB) SEPTEMBER 27, 2016

Balanced spinal solutions provider Amendia Inc. is pleased to announce the commercial launch of its innovative Spondylolisthesis reduction system:, the Syzygy™ Stabilization System. Configured to provide immobilization and stabilization of spinal segments as an adjunct to fusion, Syzygy is ideal for use in the treatment of specific acute and chronic instabilities or deformities of the thoracic, lumbar, or sacral spine; and conditions such as fracture, dislocation, scoliosis, kyphosis, spinal tumor, or failed previous fusion.

Made of implant-grade titanium alloy, the Syzygy system features cannulated and non-cannulated screws, with self-tapping “grip quick” threads for maximum cortical bone purchase. Extended threads allow increased adjustability and control in 5mm increments for accurate reduction of spondylolisthesis. With available medial and cranial couplers, Syzygy facilitates up to 35mm of reduction with ±10° of cranial-caudal adjustment.

Dr. Hewatt M. Sims, MD, fellowship-trained orthopedic spine surgeon at Orthopedic Spine Center and Tift Regional Medical Center in Tifton, GA, performed recent spine surgeries with Syzygy. “Syzygy is a unique spinal system, providing quick, precise, and consistent reduction of the spondylolisthesis deformity,” Dr. Sims said.

The Syzygy system’s advanced design features, such as extended threads on each MAC Pin enable precise corrections and dual scales enhance optimal sagittal alignment.

“In working hand in hand with the medical community and spinal device marketplace, we know how important it is to provide patients and surgeons with a pedicle screw-based solution that consistently and accurately realigns the spine,” said Lawrence Boyd, Amendia’s Executive Vice President of Research & Development. “With surgeons providing care for a large number of patients who engage in athletics and rigorous physical activity, combined with a growing aging population, this critical addition to our line of lumbar fixation products will provide another way for surgeons to evolve and innovate their care.”

The Syzygy Stabilization system is part of Amendia’s growing list of products for balanced solutions for lumbar fixation systems. To learn more about Syzygy, including features and benefits and 510(k) information, please visit us at http://www.amendia.com.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, GA, Amendia is a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visit http://www.amendia.com.

CurveBeam Announces Development of Extremity CT System for Knee

A new orthopedic CT system promises to improve the standard of care for knee imaging. On the CurveBeam LineUp, patients are scanned while standing upright and fully weight bearing.

Traditional CT and MR images are acquired in a non-weight bearing position, leading to “missed diagnoses of meniscal damage,” according to Dr. Neil Segal, who has been overseeing research efforts using a LineUp prototype, first at the University of Iowa and currently at the University of Kansas.

Although plain radiographs can be acquired while the patient is in a full weight-bearing position, the optimal degree of knee flexion and X-Ray beam tilt to best visualize the joint surface is person specific.

“Difficulty in reproducing the same view of the joint over time impairs ability to detect joint disease, and the 2D nature of radiographs makes these images of overlapping bony anatomy very insensitive for detecting abnormalities until there is advanced joint damage,” Dr. Segal said.

The LineUp was developed by CurveBeam, a Pennsylvania-based company that specializes in extremity cone beam CT systems for orthopedics. CurveBeam anticipates it will submit an application for and receive FDA 510(k) clearance for the LineUp in 2017. The LineUp will be on display at RSNA at Booth #8008 in the North Hall.

CurveBeam introduced the pedCAT, a bilateral weight bearing CT system dedicated to the foot and ankle, in 2012. Since then, the device has been added to the imaging services of hospital foot & ankle sections, orthopedic clinics and podiatry offices.

Like the pedCAT, the LineUp will provide isotropic, three-dimensional volumes of the anatomy with a high resolution output of between 0.2 mm and 0.3 mm slices. The LineUp will be the only cone beam CT system that can provide bilateral, weight bearing scans.

A study led by Dr. Segal focused on osteophytes, one structure linked to pain in people with knee osteoarthritis. Knees of community-dwelling adults with knee OA were imaged with MRI (reference), fixed-flexion radiographs, and weight bearing CT. The sensitivity and accuracy for detecting osteophytes and subchondral cysts were higher with weight bearing CT imaging in comparison to fixed-flexion radiographs. The study was published in the August 2016 issue of the Journal of Orthopedic Research.

“Clinically, this is a highly meaningful improvement,” Dr. Segal said. “It suggests that weight-bearing CT could replace radiographs as the recommended means of assessing knee OA. This advancement is even more significant given that it was made without significantly increasing the radiation dose (0.01 mSv for SCT vs. 0.005–0.102 mSv for a series of knee radiographs).”

Another research effort led by Dr. Segal indicates weight-bearing CT arthrography studies can provide outstanding delineation of articular cartilage with better differentiation between cartilage and subchondral bone then MRI studies, while also visualizing the cruciate ligaments. In knees with osteoarthritis, meniscal tears not visualized on MRI were detectable on weight-bearing CT.

“Thus, we found that some potential advantages of weight-bearing CT over non-weight-bearing MRI/MRA include 3D measures of meniscal position, detection of pathology not detected in unloaded positions, and ability to bear weight in a functional position, thus better recreating the magnitude of body weight and muscle forces acting around the knee during usual standing,” Dr. Segal said.

Spineology Inc. Announces Unique TLIF Insertion Options for the Posterior Midline Approach ACT MediaLIF™

September 27, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today the availability of multiple transforaminal lumbar interbody fusion (TLIF) technologies as part of the Anatomy-Conserving Medial Lumbar Interbody Fusion (ACT MediaLIF™) platform. These TLIF technologies allow for TLIF placement of interbody devices using a direct posterior, or ACT MediaLIF, approach.

“Surgeons frequently prefer placing a single cage using the TLIF technique over more traditional PLIF techniques, but experience difficulty with TLIF when using the latest mini-midline techniques,” said John Booth, CEO of Spineology Inc. “These unique technologies allow surgeons to use a TLIF technique and still take advantage of the benefits that the ACT MediaLIF procedure provides.”

Dr. Vivek Mohan, MD, of Dupage Medical Group in Chicago added, “Having technology that allows me to do a TLIF in conjunction with the ACT MediaLIFprocedure provides the best solution for my patients. The procedure allows me to reduce the incision size and muscle trauma, and minimize the amount of bony removal to place the cage. It also facilitates anterior cage placement to maximize lordosis restoration.”

The ACT MediaLIF procedure combines Spineology’s Medius Retractor, Rampart Interbody and Fortress Pedicular Fixation Systems to provide an anatomy-conserving approach to posterior lumbar surgery that can reduce incision length, dissection and retraction requirements compared to traditional open surgery.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

joimax® Announces Release of First Endoscopic AMA CPT Code

September 26, 2016

IRVINE, Calif.–(BUSINESS WIRE)–The AMA (American Medical Association) released the CPT 2017 Codebook (Current Procedural Terminology), now containing the first endoscopic spinal surgery code no. 62380. This new code covers endoscopic decompression of the spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar, and will be enforced as of January 1st, 2017. Under this code the specific transforaminal (TESSYS®) and/or interlaminar (iLESSYS®) procedures are fully covered in the USA herewith, which are already marketed by joimax® in 45 countries.

“The definition of this new code in the CPT codebook 2017 is a major milestone towards the acceptance of endoscopic minimally invasive spine surgery techniques and its benefits to both the surgeon and their patients,” states Wolfgang Ries, Founder and CEO of joimax®. Since 2012 joimax® had been driving this effort to obtain CPT codes as these procedures required submission to payors for reimbursement coverage which was granted only in single cases under temporary codes, so-called T-codes.

“joimax® has been instrumental in driving the effort to obtain full code coverage of endoscopic spinal surgery,” says Daniel Laich, DO, Swedish Convenant Hospital, Chicago, who had been participating and presenting in almost every AMA meeting over the last five years. Due to the high research and publication activities by key users like Albert Telfeian, MD, PhD, at Rhode Island Hospital at Brown University, and a group of users around him, strong evidence has been accepted by AMA authorities, justifying the release of this new CPT code.

Many papers and publications on joimax® products can now be downloaded from the newly released joimax® homepage. The completely redesigned website offers visitors richer insight into the company’s innovative products and systems. A quick and easy access to essential information and features is available, including the latest workshop and education activities, which are essential in endoscopic minimally-invasive spinal surgery.

Meanwhile joimax® offers basic and advanced workshop training courses mainly in the USA, Germany and Austria, and oversees a participation population of almost 3,000 physicians. Independent training courses are also performed in China and Korea to support the fast growing Asian markets. Detailed information about those courses are updated regularly at www.joimax.com.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, Multiuse RT (e.g. for rhizotomy) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

joimax® GmbH
Sabine Jarosch, 49 721 25514 0
sabine.jarosch@joimax.com

New SonicOne® O.R. Data Being Presented at WUWHS 2016 Congress: Shows Effectiveness in Removing Biofilm

FARMINGDALE, N.Y., Sept. 26, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), an international ultrasonic surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic instruments for spine surgery, neurosurgery and other surgical specialties, today announced new data demonstrating the effectiveness of the SonicOne O.R. ultrasonic debridement device in removing biofilm from potentially contaminated surfaces associated with metal knee and hip implants. The data will be presented during the World Union of Wound Healing Societies (‘WUWHS”) to be held September 25 – 29, 2016 in Florence, Italy.

It is estimated that 90% of chronic wounds contain bacteria and fungi living within biofilm. The new data suggests SonicOne O.R. can play a role in addressing the significant problem biofilm plays in preventing chronic wounds from healing.

“The early data are very encouraging. The studies showed complete removal of biofilm from infected titanium plates. The plates simulated biofilm that grows on metal knee and hip implants. Biofilm formation and removal is a significant problem in infected implants,” said Dr. Mark S. Granick, Professor and Chief, Division of Plastic Surgery, Rutgers New Jersey Medical School. Dr. Granick added, “While more studies are needed, SonicOne continues to demonstrate utility as an infection control platform during wound debridement.”

Stavros Vizirgianakis, Interim Chief Executive Officer of Misonix, commented, “We are pleased that the SonicOne O.R. system is being recognized as a viable solution to a recurring problem that can profoundly impact the quality of life for the growing number of implant recipients throughout the world. It is gratifying that globally recognized experts like Dr. Granick are involved in this ongoing research. The SonicOne O.R. features unique attributes that can enhance healing in diabetic ulcers, wounds from burns and now, potentially, implant infections. We look forward to the forthcoming results of the ongoing research.”

Misonix also announced a Live YouTube event from Florence, Italy featuring Dr. Granick’s presentation during the World Union Wound Healing Society Meeting. The Live event can be viewed at https://www.youtube.com/embed/VZ3udLGk0e4 on Monday, September 26th at 5 pm EST.  The presentation is expected to cover the clinical benefits of the use of the newly launched SonicVac® addition to the SonicOne O.R. device.  The SonicVac, which was launched in April of this year, uniquely combines aspiration and ultrasound during wound debridement. This combination reduces spray during the procedure while capturing debris and bacteria from the wound.

“We’re particularly excited that Dr. Granick is hosting this event and we look forward to his live presentation at WUWHS 2016 for a worldwide audience.  Events like this are an important part of the Misonix education platform and will expose clinicians from around the world to our unique technologies,” states Scott Ludecker, Senior Vice President, Global Sales and Marketing with Misonix.

The SonicOne O.R. System is an innovative ultrasonic surgical debridement system that allows surgeons to address the challenges chronic wounds present to them, the patient and the healthcare system. SonicOne O.R. establishes a new standard in surgical wound bed preparation, an essential first step in the wound healing process.  The new SonicOne procedure will be sold and distributed through the Misonix sales team in the United States and its domestic and international distribution networks.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies.

Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications.  Additional information is available on the Company’s Web site atwww.misonix.com.

Corporate Contact
Misonix Contact:  Investor Contact:
Richard Zaremba Joe Diaz
631-694-9555 Lytham Partners
invest@misonix.com 602-889-9700
info@misonix.com

 

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the completion of the investigation related to identified deficiencies in internal control over financial reporting, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Logo – http://photos.prnewswire.com/prnh/20160201/328020LOGO

 

SOURCE Misonix, Inc.

Related Links

http://www.misonix.com

Stryker to host conference call on October 27, 2016

Kalamazoo, Michigan – September 26, 2016 – Stryker Corporation (SYK) announced that it will host a conference call on Thursday, October 27, 2016 at 4:30 p.m., Eastern Time, to discuss the Company`s operating results for the quarter ended September 30, 2016 and provide an operational update. Final operating results for the quarter ended September 30, 2016 will be released at 4:00 p.m. that day.

 To participate in the conference call dial (844) 826-0610 (domestic) or (973) 453-3249 (international) and be prepared to provide conference ID number 57981183 to the operator.

A simultaneous webcast of the call will be accessible via the Company`s website at www.stryker.com. The call will be archived on the Investors page of this site.

A recording of the call will also be available from 8:00 p.m., Eastern Time, on Thursday, October 27, 2016, until 11:59 p.m., Eastern Time, on Thursday, November 3, 2016. To hear this recording you may dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and enter conference ID number 57981183.

Forward-looking statements
This presentation may contain information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker is one of the world`s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.  Please contact us for more information at www.stryker.com.

Contacts

For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:
Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Stryker Corporation via GlobeNewswire

ulrich medical USA® Announces Product Line Extension, Releases uCerv® Titanium Cervical Interbody System

ST. LOUIS, Sept. 26, 2016 /PRNewswire/ —ulrich medicalUSA, Inc., a medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the U.S. market release of uCerv titanium spinal implants as an adjunct to its current uCerv PEEK OPTIMA® Interbody System which is an existing product used for anterior cervical discectomy and fusion (ACDF) surgical procedures.

“Spinal implants made from solid titanium alloy can support bone growth at the fusion site by providing proven and reliable structural integrity,” said Ali A. Baaj, M.D., Assistant Professor of Neurological Surgery at Weill Cornell Medical College in New York. “I like the easy-to-use uCerv instrumentation which incorporates a slim designed inserter that allows for superior visualization and unimpeded work space at the surgical site.”  Dr. Baaj went on to say, “This product line also features a beneficial large graft window which allows for the usage of maximum bone graft material and it is available in a wide variety of sizes.”

The uCerv titanium implants have a roughened-surface design with a trapezoidal shape and are available in parallel or lordotic configurations of various heights in small, medium and large footprints. In addition, these implants feature optimal teeth patterns on the superior and inferior surfaces to limit migration.

For more information, please visit www.ulrichmedicalusa.com.

About ulrich medical USA, Inc.
ulrich medical USA, Inc. is a privately-held subsidiary of ulrich medical®, an innovative medical technology company headquartered in Ulm, Germany which is celebrating 104 years in business in 2016.

Company Contact: e.laskey@ulrichmedicalusa.com

Photo – http://photos.prnewswire.com/prnh/20160913/407241

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/ulrich-medical-usa-announces-product-line-extension-releases-ucerv-titanium-cervical-interbody-system-300329631.html

Stryker Hip Replacement Helpline Recall Alert

FORT LAUDERDALE, Fla.Sept. 23, 2016

 

Stryker Hip Replacement Metal V 40 Femoral Heads Recall Alert
Stryker Hip Replacement Helpline is gearing up for a nationwide outreach to all people to alert them to the fact that Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. This affects the Exeter, Citation, Meridian, Reliance, Definition, Restoration, Accolade Rejuvenate and ABG 2 stems. The Helpline want to inform all Stryker Hip Replacement recipients that failure of these heads is caused by corrosion and metal debris at the junction between the metal head and neck. The clinical results for patients include pain, loss of mobility, ambulation problems and an inability to work. Poisoning of the soft tissue, muscle and bone are the cause. Revision surgeries are needed due to premature failures. Patients with V40 metal heads that suffer hip poisoning have substantial medical and legal needs.

This is a major undertaking to locate all patients with a Stryker Hip Replacement to be a part of the expected lawsuits for complications such as wear debris, metallosis, joint destruction, infection and need for additional revision surgeries.

The Stryker Hip Replacement Helpline is gearing up for what they feel is a second round of Stryker Hip Replacement lawsuits. “We expect a new wave of T.V. ads by lawyers. Patients will see lawyer ads on T.V. and they will have a lot of questions. They want to speak to someone they feel safe and comfortable with and they call us,” says the helpline medical social worker at 1 877 522-2123.

The outreach is a massive undertaking for the Stryker Hip Replacement Helpline. Their mission is clear and they are ready. They expect to be adding 5-10 new cities a week until they have the major cities in the U.S. covered. The helpline is seeking all people Implanted with a Stryker Exeter, Citation, Meridian, Reliance, Definition, Restoration, Accolade Rejuvenate and ABG 2 stems who are starting to have complications or whose physicians have received the recall letter from Stryker. If you have a Stryker hip replacement, we suggest you contact your physician to find out if they have received the letter and to confirm what type of hip replacement you have. Call the helpline immediately after that.

Stryker Hip Replacement Helpline Recall Alert Outreach Begins

Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. Specifically, these metal heads are associated with wear debris, metallosis, joint destruction, infection and need for revision surgery.

The first round of Stryker V40 femoral heads recall Outreach is projected to reach the following cities:

New York, N.Y.,
Los Angeles, Calif.,
Chicago, Ill.,
Houston, Texas,
Philadelphia, Pa.,
Phoenix, Ariz.,
San Antonio, Texas,
San Diego, Calif.,
Dallas, Texas,
San Jose, Calif.,

Second Stryker Hip Replacement V40 femoral heads Outreach Campaign

Jacksonville, Fla.,
Indianapolis, Ind.,
San Francisco, Calif.,
Austin, Texas,
Columbus, Ohio,
Fort Worth, Texas,
Charlotte, N.C.,
Detroit, Mich.,
El Paso, Texas,
Memphis, Tenn.,

Third round Stryker Hip Replacement V40 femoral heads recall outreach alert

Baltimore, Md.,
Boston, Mass.,
Seattle, Wash.,
Washington, DC,
Nashville
Denver, Colo.,
Louisville,
Milwaukee, Wis.,
Portland, Ore.,
Las Vegas, Nev.,

Additional Lawsuits Outreach

Oklahoma City, Okla.,
Albuquerque, N.M.,
Tucson, Ariz.,
Fresno, Calif.,
Sacramento, Calif.,
Long Beach, Calif.,
Kansas City, Mo.,
Mesa, Ariz.,
Virginia Beach, Va.,
Atlanta, Ga.,
Colorado Springs, Colo.,
Omaha, Neb.,
Raleigh, N.C.,
Miami, Fla.,
Cleveland, Ohio,
Tulsa, Okla.,
Oakland, Calif,.
Minneapolis, Minn.,
Wichita, Kan.,
Arlington,

Stryker Hip Replacement Recall Alert

Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. Specifically, these metal heads are associated with wear debris, metallosis, joint destruction, infection and need for revision surgery. Stryker Hip Replacement Helpline has a dedicated number for assistance 1 877 522-2123 or contact us using the contact form of the website.

http://strykerhipreplacementhelpline.com/

Contact
Lisa Spitzer MSW
***@strykerhipreplacementhelpline.com

Zimmer Biomet to Feature Clinical Data on the Aspen® MIS Fusion System and the Timberline® Systems during the Congress of Neurological Surgeons (CNS) Annual Meeting

Broomfield, CO – September 26, 2016 – Zimmer Biomet Spine, Inc. today announced positive topline data on the Aspen MIS Fusion System and the Timberline Systems from three studies validating less invasive treatment methods for degenerative disc disease and spondylolisthesis. The studies will be presented as ePosters during the Congress of Neurological Surgeons Annual Meeting (CNS), September 24 to 28 in San Diego.

“Zimmer Biomet’s clinical data demonstrates the benefits of less-invasive spinal fusion techniques, at a time when the industry is continuing to improve minimally invasive treatment options for patients,” said Adam Johnson, Group President of Zimmer Biomet Spine, Dental, CMF and Thoracic. “We look forward to discussing the one-year outcomes of our randomized controlled trial, as well as executing more research in the future so we can continue to develop the evidence necessary to support excellent patient outcomes.”

Demonstrations of the Aspen MIS Fusion System and the Timberline Systems will be available at Zimmer Biomet Booth #429.  

ePosters: 

  1. Interspinous Process Fixation versus Pedicle Screw Fixation in Circumferential Arthrodesis: Outcomes from a Prospective Randomized Multi-Center Trial(ePoster 1287)

Lead Investigator: Dr. Kee Kim; UC Davis Health System, Dept. of Neurosurgery

Product Focus: Aspen MIS Fusion System

 

  1. Lateral Lumber Interbody Fusion with Integrated Lateral Modular Plate Fixation: Intraoperative and Follow-Up Outcomes (ePoster 1312)

Lead Investigator: Dr. Ryan DenHaese; AXIS Neurosurgery and Spine

Product Focus: Timberline MPF Lateral Fixation System; Aspen MIS Fusion System

 

  1. Anterior Versus Lateral Circumferential Lumbar Arthrodesis: Outcomes from a Prospective Multi-Center Study (ePoster 1301)

Lead Investigator: Dr. Kee Kim; UC Davis Health System, Dept. of Neurosurgery

Product Focus: Timberline Lateral Fusion System; Aspen MIS Fusion System

 

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare.  We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation.  Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues.  Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries.  For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.