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The Maglio Christopher & Toale Law Firm has filed suit in Federal District Court against Zimmer, Inc. on behalf of a client with a failed Durom Hip Replacement Cup. It is believed that this is the first lawsuit to be filed against Zimmer regarding its controversial Durom Hip Replacement System. The Firm plans to file additional Durom lawsuits against Zimmer on behalf of other clients in the coming weeks.

Sarasota, FL (PRWEB) August 12, 2008 -- The Maglio Christopher & Toale Law Firm has filed suit in Federal District Court against Zimmer, Inc. on behalf of a client with a failed Durom Hip Replacement Cup. Zimmer is a multinational medical device manufacturer. It is believed that this is the first lawsuit to be filed against Zimmer regarding its controversial Durom Hip Replacement System. The Firm plans to file additional Durom lawsuits against Zimmer on behalf of other clients in the coming weeks.

Problems with the Zimmer Durom were put in the spotlight on April 22 of this year when a highly respected orthopedic researcher, surgeon, and director of the Dorr Institute for Arthritis Research and Education, wrote a letter to his colleagues at the American Association of Hip and Knee Surgeons, criticizing the device. In his letter, Lawrence Dorr, MD, reported that 14 of the 165 Durom hip systems implanted at his clinic needed to be surgically revised within two years of implantation. He wrote:

"In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated on the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions." It was another three months before Zimmer finally stopped selling its Durom Hip Resurfacing System. On July 22, 2008, Zimmer issued a press release announcing that it was "temporarily suspending marketing and distribution of the Durom Acetabular Component in the U.S. on a voluntary basis, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S."

In its release, Zimmer admitted that the Durom cup was failing at a higher than expected rate. However, it went on to blame the high rate of failure on surgeon error rather than on the Durom cup. Orthopedic surgeons familiar with the Durom have disagreed, indicating that the widespread nature of the failures shows the problem to be with the cup and not surgeon error.

Zimmer estimates that as many as 12,000 patients in the United States currently have the Durom Cup implanted in their hips.

About the Maglio Christopher & Toale Law Firm

The Maglio Christopher & Toale Law Firm has successfully represented patients across the nation in obtaining compensation for injuries caused by defective hip and knee joint replacement devices.

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August 7, 2008

Europe's largest medical devices firm, Smith & Nephew, which manufactures hip implants in Birmingham, has posted better-than-expected second-quarter earnings as revenues hit £500 million for the first time, boosting its stock.

The group confirmed its outlook for the full year, including the impact of problems at its Plus Orthopaedics, where the company revealed it had uncovered "unacceptable" sales practices three months ago.

Chief executive David Illingworth said: "We have generated quarterly revenues of $1 billion (£512 million) for the first time, as a result of a very solid performance across all of our businesses."

"In Reconstruction we have seen good growth in both our hip and knee product lines; in Trauma the actions we have taken in sales management have begun to pay off; Endoscopy has delivered double-digit revenue growth and in Advanced Wound Management we have outperformed the market. We are confirming our guidance for the full year and we believe that the long term outlook for our business is excellent," he added.

In Orthopaedic Reconstruction, global hip revenue growth was a solid seven per cent due to good contributions across all products and regions.

The Birmingham Hip Resurfacing System now has an estimated 3.5 per cent share by volume of the total US hip market after only two years in the market.

Investors welcomed the performance.

Nomura Code analyst Charles Weston said: "All the divisions did well on their sales and they've confirmed that the sales hit from Plus will be $100 million (£51 million), which is effectively positive because there are no new negatives."

Pre-tax profit rose to £80 million from £75.3 million a year earlier. Sales were £512 million, an underlying increase of eight per cent, or 23 per cent on a reported basis.

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Aug. 8, 2008

Since its introduction a decade ago, metal-on-metal hip resurfacing has become increasingly popular because it may conserve femoral bone, increase functional ability and be easier to revise than other procedures, according to an article published in the August issue of the Journal of Bone & Joint Surgery.

Michael A. Mont, M.D., of Sinai Hospital of Baltimore, and a colleague reviewed clinical results - primarily from studies conducted in England, Australia and Western Europe -- and highlighted 10 important lessons learned during the past 10 years.

The researchers found that metal-on-metal hip resurfacing now accounts for about 10 percent of total hip arthroplasties. Among the lessons they highlight is that patient selection is the key to success. They cite Australian data on more than 10,000 patients showing that metal-on-metal hip resurfacing is associated with similar or improved survivorship compared to standard total hip arthroplasty in men under age 65 but not in men over age 65, and that metal-on-metal hip resurfacing is associated with a higher risk of short-term failure in men over age 65 and in all women.

"In the Australian registry, hips that underwent resurfacing as treatment for osteoarthritis have had better survival than those that underwent resurfacing for the treatment of developmental dysplasia, inflammatory arthritis and osteonecrosis," the authors write. "In summary, resurfacing hip arthroplasty has had a tremendous increase in popularity because of the potential benefits of femoral bone conservation, possible increased functional ability, and ease of potential revision procedures. In young men, the survivorship has been similar to that of standard total hip arthroplasty."

Although none of the authors received outside funding or grants in support of their research, one or more of them reported that they or their family members received grants or payments from Wright Medical and DePuy during the past year.

 

Link  http://www.govhealthit.com/online/news/350502-1.html

By Peter Buxbaum  Published on August 4, 2008

The Food and Drug Administration has proposed a program that would query public and private databases to help study the efficacy of orthopedic implants.

FDA will issue a request for quotations next month in an effort to identify companies that could evaluate orthopedic implant registries for participation in the program.

The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader effort is intended to monitor and provide early warnings of potential problems with FDA-approved medical products.

The implant program would “create a national network of registries for the FDA in support of the Sentinel Initiative,” according to an FDA announcement posted July 25. Implants of interest would include total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices.

The program would create a distributed network to enable FDA to query multiple data sources for information about medical products. As envisioned, queries to the network would be accomplished with minimal data transfer and would protect patient privacy.

FDA’s current post-market surveillance programs require “health care professionals and patients to first recognize an association between an adverse effect and a medical product, and then report it to FDA,” an FDA spokesperson said. “Most adverse events are never reported, and when they are, the information provided is incomplete.”

FDA officials envision being able to search government databases, such as the Medicare database, private and public medical claims databases, and electronic health record systems, the spokesperson said.

The proposed evaluations of the orthopedic implant registries will lead to recommendations for involvement of the most promising data sources, the FDA announcement states.

The Sentinel Initiative “could also ultimately facilitate data mining and other research-related activities,” the spokesperson added.