General Information

Link  http://www.iol.co.za/index.php?set_id=1&click_id=13&art_id=vn20060821014255934C837090

By Karen Breytenbach

Two American orthopaedic surgeons have been taught an innovative hip surgery technique by a local surgeon.

Leith Stewart, an orthopaedic surgeon at Claremont Hospital (South Arfrica), last week demonstrated the Birmingham Hip Resurfacing (BHR) procedure to his guests, Ian Kovack from Kansas and Donald Polakoff from New Jersey.

One patient was a professional golfer in her 30s and the other an active woman in her 60s. Both were told they would be up and on crutches within two days, instead of six weeks if normal surgery was done.

Both will also be able to drive, cycle and swim within three weeks instead of six.

Stewart, an avid cyclist and snowboarder, has been performing the procedure for six years. He had a BHR performed on his left hip about four years ago, with great success.

Since 1997 the procedure, developed by two British surgeons as a bone conserving alternative to total hip replacement, has been used on about 51 000 patients in the UK, Germany, Australia and South Africa.

The procedure was only recently approved by the US Food and Drug Administration, on condition that surgeons receive training.

While total hip replacement has yielded good results in elderly inactive people, the procedure has been less successful in young and active people, who respond better to resurfacing.

Hip resurfacing is the replacement of the cartilage covering the surfaces of the ball at the end of the thigh bone (femur) and the cup-shaped cavity (acetabulum) into which it fits, with cobalt chrome, into which bone grows" in weeks".

• This article was originally published on page 4 of The Cape Times on August 21, 2006

 

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)

Nerve palsy 'a vexing complication' in total hip replacement

Link  http://www.orthosupersite.com/view.asp?rID=25738

1st on the web (January 17, 2008)
January 2008

LAHAINA, Hawaii — While the overall incidence of nerve palsy resulting from total hip replacement remains low, patients undergoing revision surgery have a threefold risk for nerve injury, and women are at a higher risk than men.

Thomas P. Schmalzried, MD, of St. Vincent Medical Center in Los Angeles, said that in an analysis he conducted with colleagues S. Noordin, MD, and Harlan C. Amstutz, MD, of more than 34,000 total hip replacements (primary and revision), there were 359 nerve palsies — a 1% overall prevalence. However, the incidence among revision surgeries escalated to 2.5%, (0.9% for primary cases), and patients with developmental dysplasia of the hip (DDH) demonstrated a 5% risk for nerve palsy.

Even more alarming: nerve palsy occurred in women nearly twice as much as men, he said.

"What this all says to me is that anatomy plays a role," he told attendees at Orthopedics Today Hawaii 2008, here. "Nerve palsy is a vexing complication. You might be doing what you usually do, but because of the variances in anatomy — if the nerve isn't where it usually is or if it takes a course around the hip joint different from where it usually goes — indirect injury may be the result."

He said the sciatic nerve is the most frequently injured nerve in THR, accounting for 79% of all nerve palsies. Injury to the sciatic nerve or the peroneal division of the sciatic nerve typically occurs proximally at the level of the hip joint.

Electromyography has demonstrated evidence of nerve injury in 70% of extremities following THR, he added.

"In our research, femoral nerve injuries tend to be more frequent when we use an anterolateral approach to THR," he said. This is because the femoral nerve is close to the anterior aspect of the hip joint and, consequently, to the anterior acetabular retractors.

Schmalzried said that if neuropathy is suspected in a THR patient, the orthopedic surgeon should consult with the neurologist.

"Be nice to your neurologist," he said. "He can help you validate your findings and identify the exact source or location of the nerve injury."

For more information:

Schmalzried TP. Nerve and vascular injuries associated with total hip arthroplasty. Presented at Orthopedics Today Hawaii 2008. Jan. 13-16, 2008. Lahaina, Maui, Hawaii.
 

Hip resurfacing: Time for a second look
 

Link   http://www.orthosupersite.com/view.asp?rID=25098

Newer implants with proper patient selection may make this a better procedure.
 

By Keith R. Berend, MD
ORTHOPEDICS TODAY 2007; 27:82
December 2007

In terms of hip resurfacing versus total hip arthroplasty, the questions we have to address are: Is metal-on-metal the right choice for the patient; Is the resurfacing more conservative; What are the indications for resurfacing; and Is the large head metal-on-metal total hip better in most patients than a resurfacing?

Keith R. Berend

"Studies show that men who jog at least once a week have roughly 5% denser bones than men who don't jog but are otherwise active.

 

This could be a chicken or the egg thing; whether the men who naturally take to jogging have denser bones to start, or if the jogging itself causes density changes. What is important here is that a runner will have a different presentation than a non-runner when undergoing a surgical correction like a BHR.

 

If you have never played football, then taking up football at the age of fifty might not be a good idea. Running is the same. I have been running for more than thirty years at the marathon distance and beyond, and during that time I have seen hundreds and hundreds of weekend warriors come and go, putting bodies that were never designed for running through their paces until the bodies broke. Knee injuries, foot injuries, plantar fascitis, IT syndrome, on and on - all possible signals that your body was not designed to run. I have never suffered an injury from running [beyond an occasional blister]; if I did I doubt I would continue it. Each person has a different genetic package they bring to the table.

 

The results of over 855 hip resurfacing patients who participated in the Yahoo Surface Hippy Survey are now available at the Surface Hippy Webiste.

 

The survey asked 40 detailed questions about the patients hip resurfacing experience and surgery. The survey is extremely interesting and fact filled about pre-op conditions, surgery information and post-op recoveries with return to sports and normal activities.

 

Click below to view the Yahoo Surface Hippy Survey

 

Yahoo Surface Hippy Survey Results