HR Issues

Link http://goreflector.com/articles/2007/12/01/news/business/iq_459788.txt

Saturday December 01 2007, 1:16am

Dr. David Pocos of Northern Ohio Medical Specialists (NOMS) Access Orthopaedics has recently completed advanced training in the Cormet hip resurfacing arthroplasty, a conservative alternative to total hip replacement.

The procedure is ideally suited for younger, more active patients. The Cormet better maintains the normal mechanics of the joint, while preserving bone.

Pocos graduated from the Ohio University College of Osteopathic Medicine and did his residency training in Cleveland. He then went on to complete a fellowship in total joint replacement at the Cleveland Clinic Foundation.

He is a member of the NOMS with offices in Norwalk and Willard. He resides in Norwalk with his wife and three children.

To schedule an appointment to find out if you may be candidate for the Cormet hip resurfacing, call Dr. Pocos at (419) 663-5000.

Link  http://www.memphisdailynews.com/Editorial/StoryLead.aspx?id=100097

Though the Birmingham hip is considered the industry standard, founders of another Memphis company, Active Implants Corp., said they believe they can play leapfrog with hip resurfacing using an advanced polymer first developed for Israeli Navy boat hulls.

"We're now approved in all of Europe," said Stephen Bradshaw, president and CEO of Active Implants. "We start hip surgery this week in Germany, Italy, Greece and Israel. My technology will not be available in the U.S. for quite a while, and we already have patients planning to go to Europe to get it done."

He's careful not to criticize the FDA's gate keeping, but said that new medical technology will continue to emerge first in Europe.

"I'm going to where the market opportunity is," he said. "They do almost 200,000 hip replacements a year in Germany, so it's high volume and a more friendly regulatory environment. That's why you have medical tourism; it's not the cost, but countries outside the U.S. are getting new technology faster."

Know thy information

Younger, better informed patients are not afraid of flying to Europe or even India for surgery, Bradshaw said.
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That compels manufacturers to present accurate information on their Web sites, Waugh said, and usually to assist people in finding a doctor who is familiar with the procedure.

"Surgeons have turned this into a marketing opportunity," he said. "A person wants to go to a surgeon with experience."

The AOA hip report bodes well for all manufacturers in the arena, Bradshaw said, alleviating early concerns that resurfacing may not be viable because the components are so small compared to traditional implants. With that concern gone, he said, it's now time for companies to duke it out based on clinical performance.

The AOA exhaustively collects implant data from surgeons across Australia, publishing unbiased statistics on such things as the number of procedures, component years, and revision rates, which are repeat surgeries to replace or repair an implant.

In Australia the Birmingham hip has been implanted 6,773 times, logging 19,585 component years, a cumulative measure of years in use - a common measure when assessing durability. Of those, 166 hips saw revision, a rate of 2.5 percent, by far the lowest rate. Other brands had revision rates of 4.4 percent to 8.4 percent.

"The AOA gets excellent participation; it's one of the most compliant registries in the world," Waugh said. "Whether you're an orthopedic manufacturer or a surgeon, this is a great way to see how something performs in the real world."

Counting sheep

Expect to see Smith & Nephew use the findings in educational materials for both surgeons and consumers. The Internet has permanently altered the way people manage their health care, Waugh said, with patients armed with information to discuss with their doctors.

That's already evidenced by aging athletes who have become celebrity spokespeople for implants. Tennis star Jimmy Connor plugs the Conserve total hip, manufactured by Wright Medical Technology Inc. of Arlington. At 38, former Olympic gymnast Mary Lou Retton got a new hip from Biomet Inc. of Warsaw, Ind. Golfer Jack Nicklaus was so pleased with his hip from Stryker Corp. that he's now its spokesman.

One budding issue in orthopedics is metal ionization, the microscopic fragments of metal that rub off a device and enter the blood stream. Some early studies suggest that metal-on-metal has a higher ionization rate compared to metal-on-plastic, but there is no evidence that this has any detrimental effects. What is proven is that metal-on-plastic releases polyethylene, linked to a condition that causes bone to shrink and eventual implant failure.

A 1999 study at the Avon Orthopaedic Centre in Bristol, England, compared both types and found the metal-on-metal ionization not to be significant.

Bradshaw said he can avoid that entire concern with his polycarbonate products. In one test, researchers at Leeds University in England subjected the material to 5 million cycles - equal to about 10 years worth of walking - and found no wear.

As an aside, Active Implants is also developing an artificial meniscus, or fibrous cartilage within a joint, from the same material to treat torn cartilage in the knee. The meniscus is now undergoing field trials. Because sheep knees are similar to human knees, dozens of the animals are scampering around a pasture in Israel with a polycarbonate meniscus.<

Link http://www.medcompare.com/litupdate.asp?ArticleID=14960&typeid=24

1/1/2008

Journal: Clinical Orthopaedics and Related Research

Citation: 465:71-79, December 2007.

Authors: Carolyn Anglin, PhD, PEng; Bassam A Masri, MD, FRCSC; Jérôme Tonetti, MD; Antony J Hodgson, PhD, PEng; Nelson V Greidanus, MD, FRCSC

Femoral neck fracture is the most common short-term concern after hip resurfacing arthroplasty. Currently, there is little basis to decide between neutral and valgus placement. We loaded 10 notched cadaveric femur pairs to failure; one side was implanted at 0[degrees] relative to the femoral neck and the other at 10[degrees] valgus. All 20 were dual-energy xray absorptiometry-scanned. Failure load correlated with bone mineral density. Valgus placement increased the fracture load by an average of 28% over neutral for specimens with normal bone mineral density but had no effect on fracture load in specimens with low bone mineral density. For specimens with normal bone mineral density (typical of patients undergoing resurfacing arthroplasty), neutral-valgus placement had a greater effect than bone mineral density, explaining 54% of the fracture load variance. Component placement greater than 10[degrees] valgus is likely undesirable because this can lead to an increase in component size and a greater likelihood of notching. To reduce fracture risk, we recommend placing the femoral component in valgus and selecting patients with higher bone mineral density.

Link 

http://phx.corporate-ir.net/phoenix.zhtml?c=118965&p=irol-newsArticle&ID=1098406&highlight=

Stryker Issues Statement Regarding FDA Warning Letter

KALAMAZOO, Mich., Jan. 22 /PRNewswire-FirstCall/ -- Stryker Corporation (NYSE: SYK) today issued the following statement in response to recent media attention regarding a Warning Letter dated November 28, 2007, that the United States Food and Drug Administration (FDA) published on its web site on January 15, 2008.

While Stryker does not normally comment on discussions with the FDA, the Company believes it is obligated to provide additional information to healthcare professionals, providers and patients in light of several media reports that draw erroneous conclusions surrounding the Warning Letter.

Most importantly, the Company does not believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients. Numerous published independent reports validate the long-term clinical performance of these products.

The Company takes these matters very seriously and has been cooperating fully with the FDA to address questions related to the FDA's observations of Stryker's internal process specifications. As part of a comprehensive review of internal processes following the FDA's observations, the Company conducted an investigation into a deviation from its internal specifications and processes for the Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork, Ireland facility.

The internal investigation confirmed that all Trident Acetabular products manufactured in Cork, Ireland, have met all U.S. and international performance standards for sterility and biocompatibility. However, results from that testing indicated that the level of manufacturing residuals in some cases exceeded the Company's internal acceptance criteria. It is important to note this in no way impacts the product's sterility, nor product conformance to U.S. and international biocompatibility standards. As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility. Medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products. In fact, independent clinical evidence confirms that the performance of these cups compares very favorably with other high performing acetabular devices.(1,2,3)

Trident Acetabular Cups manufactured in the Company's Mahwah, New Jersey facility are not part of the voluntary recall and are still available to supply Stryker's customers.

The Company anticipates some short-term supply disruption as a result of this action and is focused on eliminating these disruptions as expeditiously as possible. In that regard, the manufacturing process for these cups in Cork has now been validated, product shipments have resumed and the Company has increased production at both the Mahwah and Cork facilities. Quality is a Stryker core value and the Company remains committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations, including those administered by the FDA and regulatory bodies in other countries in which Stryker conducts business.

The Company does not anticipate any material financial impact on Stryker's guidance for its 2008 results as a result of this voluntary recall. Details regarding the Company's sales and earnings outlook will be provided in conjunction with the release of its fourth quarter 2007 operating results on Wednesday, January 23, 2008.

Forward-Looking Statements

This press release contains 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 the Company's actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for the Company's products; regulatory actions; unanticipated issues arising in connection with clinical studies and eventual FDA approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; changes in economic conditions that adversely affect the level of demand for the Company's products; changes in foreign exchange markets; changes in financial markets; and changes in the competitive environment. Additional information concerning these and other factors are contained in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; and endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at www.stryker.com.

1. 2006 Annual Report of the Australian Orthopaedic Association. Retrieved
January 21, 2008, from http://www.aoa.org.au/docs/njrrrep06.pdf

2. Capello WN, D'Antonio JA, Manley MT, Feinberg JR. Arc-deposited
hydroxyapatite-coated cups: results at four to seven years. Clin
Orthop Relat Res. 2005 Dec; 441: 305-12.

3. D'Antonio JA, Manley MT, Capello WN, Bierbaum BE, Ramakrishnan R,
Naughton M, Sutton K. Five-year experience with Crossfire highly
cross-linked polyethylene. Clin Orthop Relat Res. 2005 Dec; 441: 143-
50.



SOURCE Stryker Corporation
CONTACT: Investors, Katherine A. Owen, Vice President, Strategy and
Investor Relations, +1-269-385-2600, Media, Aaron Kwittken, +1-646-747-7144,
stryker@kwitco.com, both of Stryker Corporation/
/Web site: http://www.stryker.com
http://www.aoa.org.au/docs/njrrrep06.pdf /
(SYK)

FDA Warning Letter to Stryker about hip device problems and manufacturing problems.

Link FDA Warning Letter to Stryker

FDA to Stryker: Fix hip implant flaws

Link  CNBC

By LINDA A. JOHNSON updated 5:48 p.m. ET, Wed., Jan. 16, 2008

TRENTON, N.J. - Federal regulators have ordered medical device maker Stryker Corp. to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some to have follow-up surgeries. Stryker shares fell almost 2 percent.

The U.S. Food and Drug Administration told Kalamazoo, Mich.-based Stryker in a letter that it was aware that the company has received patient complaints since January 2005 about a range of problems, including improper fitting of hip implants that caused bone fractures. Patients also have complained about pain, difficulty walking and "squeaky" joins, and some have had pieces of implant parts break off or wear down unevenly.

The six-page warning letter was prepared after FDA officials spent six weeks last summer inspecting the company's orthopedics division headquarters in Mahwah, N.J., which houses manufacturing operations, research and development and administrative offices.

The letter discusses deficiencies found during those inspections and repeatedly states that four company responses on those issues, sent between Aug. 1 and Nov. 2, were inadequate for a variety of reasons.

"Your firm has failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems," the Nov. 28 letter states repeatedly.

FDA said in the letter that if Stryker does not correct the violations promptly, FDA can act without notice and seize property, levy fines and seek injunctions. The letter also notes that the FDA will not approve sale of certain new Stryker medical devices until the violations are fixed and that it will notify federal agencies about the warning letter, so they can consider it when awarding contracts.

A heavily redacted version of the letter was posted Tuesday on the agency's Web site.

FDA noted that some parts of the plant were found to be contaminated with disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria.

"Your firm has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence," the letter states.

Stryker officials declined an interview request from The Associated Press Wednesday, but provided a prepared statement.

"We take these matters very seriously and are committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations," it said. "We have been working diligently for the past several months to respond to the FDA and will continue to work closely with them to address these matters."

Stryker was among five companies, which together provide nearly all replacement hips and knees in the U.S. market, that in September agreed to pay $310 million and accept federal monitors to settle allegations they gave doctors kickbacks to use their products.

Stryker shares fell $1.36, or 1.9 percent, to $69.75 in trading Wednesday.