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Turning complex hip revisions into efficient, reproducible surgeries with the new REDAPT PDF Print E-mail

Turning complex hip revisions into efficient, reproducible surgeries with the new REDAPT™ Revision Femoral System from Smith & Nephew

Press Release from Bloomberg

Turning complex hip revisions into efficient, reproducible surgeries with the new REDAPT™ Revision Femoral System from Smith & Nephew PR Newswire
LONDON, Nov. 15, 2012

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announces the launch of their new REDAPT™ Revision Femoral System. Designed to bring the concept of personalized patient treatments to the revision hip market, the new system's versatility allows surgeons to effectively recreate a patient's unique functionality while quickly and easily addressing issues such as poor bone quality and proximal/distal mismatch.

"With other revision systems, the main goal is simply to provide a patient with a stable joint," says Dr. Reid Brown of Louisville Bone and Joint Specialists in Kentucky. "REDAPT changes these outcome expectations to include the type of functional standards typically associated with primary total hip replacements. And, it does so with streamlined, reproducible instrumentation and a shorter learning curve."  

Unlike many of the other revision systems, the REDAPT System's unique and efficient surgical technique allows a surgeon to prepare the femoral canal and complete full hip range of motion tests completely off its instrumentation. This gives the surgeon an ability to determine precise implant position for optimal stability before introducing a solid stem, predictably within the femoral canal. The advantage of the solid, monolithic stem is that it means a surgeon can avoid placing a modular, mid-stem junction at a critical, high stress location for the stem.

Also contributing to the system's overall versatility are its two available stem styles – a Proximally Fluted (PF), or sleeveless, stem for use when proximal bone defects are limited, and a Modular Sleeved (MS) stem for cases where proximal and distal bone defects are more prevalent. During pre-launch evaluation, both stem styles received very positive reviews from surgeons. In particular, surgeons appreciated the REDAPT System's ability to provide reproducible stem positioning due to its taper design, precision instrumentation and use of Smith & Nephew's proprietary ROCKTITE™ Flutes, which deliver "rock-solid" distal fixation in all defect types. "Modularity is critical in today's increasing complicated total hip revision surgery," says Dr. Mathias Bostrom of the Hospital for Special Surgery in New York. "As the revision becomes more complex, modularity is what allows me to restore center of rotation, return leg length and provide a stable hip for my patients."

With the REDAPT System, surgeons are also able to "fine tune" the joint for leg length, offset, and version through the system's five available modular neck options; four of which can be inverted. When combined, the system's multiple head lengths and neck options mean that the REDAPT system offers surgeons 54 head center options. Each neck is compatible with Smith & Nephew cobalt chrome, ceramic, and OXINIUM™ heads.

"Our goal was to create one system that surgeons could rely on for any type of revision from mild to severe," says Gaurav Agarwal, DSVP and General Manager for Smith & Nephew's Advanced Surgical Devices Division. "Not only did we achieve our goal, we created a system that's revolutionary in its versatility, its simplicity and its reproducibility."

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping improve people's lives.  With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion.  Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

Forward-looking Statements    This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline 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: economic and financial conditions in the markets we serve, especially those affecting health care providers, payors and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in integrating acquired businesses, and disruption that may result from changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business or competitive nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain 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 caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations. Trademark of Smith & Nephew.  Registered US Patent and Trademark Office. SOURCE Smith & Nephew

Stryker Recall on Modular Neck Systems THR's PDF Print E-mail

Stryker Product Recalls

Modular Neck Stems

Information About the Voluntary Product Recall

Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular and ABG II modular-neck hip stems.

This voluntary recall was initiated due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.

Please see the FAQs below for more information.

Your Particular Implant

Your surgeon can tell you if you received a Rejuvenate Modular or ABG II modular-neck hip stem, or you may review your medical records for implant identification information. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).

If you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon and discuss your symptoms. If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you.

Stryker Faces Mounting Lawsuits over Recalled Hips PDF Print E-mail

Stryker Face Mounting Lawsuits over Recalled Hips (Total Hip Replacements)

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Stryker Faces First Lawsuit for Recalled Hip Implants PDF Print E-mail

8/9/12 from Medical Design Technology

South Florida law firm Searcy Denney Scarola Barnhart & Shipley PA (Searcy Denney) announced today that it has filed the first lawsuit against Howmedica Osteonics Corporation, dba Stryker Orthopaedics, claiming damages caused by the company’s defective and recalled Rejuvenate and ABG II hip implant systems.

The suit was filed in Bergen County, New Jersey Superior Court, by Searcy Denney and Weitz & Luxenberg on behalf of plaintiffs Dianne and Phillip Pingel. The plaintiffs allege that the defendant was negligent and failed to use reasonable care for the safety and well-being of patients in the development, testing, marketing, packaging, and selling of the defective product.

On July 4, 2012, Stryker posted a national recall of the Rejuvenate and ABG II hip implant systems apparently after receiving multiple reports of the premature failure of those implants.


Stryker Faces Additional Plaintiffs In Hip Replacement Suit PDF Print E-mail

Thursday, September 13, 2012 from the News Tribune

Same article on 9/11/12 from Consumer Affairs

By Mark Huffman

A Florida law firm suing Stryker Orthopaedics over its Rejuvenate and ABG II hip implant systems says it has added seven more plaintiffs in the case. The plaintiffs are from Florida, Minnesota and Arizona.

"We have reached a decisive stage in this litigation as legitimate claims are now proliferating nationwide," said Cal Warriner, a shareholder at firm Searcy Denney, representing the eight total plaintiffs. "The Rejuvenate System has only been on the market since 2009, yet, just a few years later, an overwhelming number of patients have suffered heavy metal toxicity."

Hip resurfacing: The metal-on-metal bearing material is not the problem PDF Print E-mail
Hip resurfacing: The metal-on-metal bearing material is not the problem

The success of total hip replacement (THR) in the 20th century has been tremendous with improvements in the durability of new designs, bearing materials and fixation techniques. However, the young and active patients have historically had high revision rates compared with older, more sedentary patients, notably when the etiology of the disease is osteonecrosis. Despite great improvements in cementless stem fixation, hip resurfacing arthroplasty (HRA) has the advantages of replicating leg length and offset, and maintaining proximal bone unlike THR. Moreover, dislocation in THR remains a problem when small femoral heads are used. Resurfacing patients also do not report thigh pain as it sometimes happens after THR.
Mortality and implant revision rates of hip arthroplasty in patients with osteoarthritis: registry PDF Print E-mail

Excerpt from BMJ:

Conclusions There is a small but significant increased risk of revision with uncemented rather than cemented total hip replacement, and a small but significant increased risk of death with cemented procedures. It is not known whether these are causal relations or caused by residual confounding. Compared with uncemented and cemented total hip replacements, Birmingham hip resurfacing has a significantly lower risk of death in men of all ages. Previously, only adjusted analyses of hip implant revision rates have been used to recommend and justify use of cheaper cemented total hip implants. Our investigations additionally consider mortality rates and suggest a potentially higher mortality rate with cemented total hip replacements, which merits further investigation.

For more read: BMJ

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