Hip Resurfacing News - HR Issues

Distribution of Chromium and Cobalt Ions in Various Blood Fractions After Resurfacing Hip Arthroplasty

nospam@example.com (Patricia Walter) — Fri, 29 Aug 2008 10:40:54 -0700

Link: Click here to view complete article

Distribution of Chromium and Cobalt Ions in Various Blood Fractions After Resurfacing Hip Arthroplasty

Leonard R. Walter MBBS(Syd), FRACS, FAOrthA, Ed Marel MBBS(Syd), FRCS Ed (Orth), FRACS, FAOrthA^a, Richard Harbury MBBS(Syd), FRACS, FAOrthA^a and Jenny Wearne RN ^aPeninsula Orthopaedics Research Institute, DEE WHY NSW 2099, Australia

Received 28 November 2006; accepted 7 July 2007

Abstract

The most appropriate blood fraction for the measurement of metal ions in patients with metal-on-metal implants is controversial. We compared chromium (Cr) and cobalt (Co) ion levels in 29 patients after unilateral hip resurfacing with a size 54-mm femoral Birmingham Hip Resurfacing Prosthesis (Smith and Nephew, London, UK). All had well-functioning arthroplasties between 5 and 59 months after implantation. Ion levels were measured in serum, plasma, red cells, and whole blood in each patient. Our results indicate that only very minor amounts of Cr and Co are associated with red blood cells, with most being associated with serum/plasma. Previous studies using corrosion to produce the ion load have showed a predominance of Cr in the red blood cells. They have also shown that the cellular uptake of Cr is an indicator of its valence. This difference in distribution with our results is indirect evidence that the Cr released from wear of this implant is probably in the more benign trivalent form. It also suggests that most of the metal loss from a normally wearing bearing may be from wear rather than corrosion. If blood is to be used to assess rates of wear and systemic ion levels, then serum gives a better reflection of the true levels than red blood cells.

Dr. Bose Transcript of Chat on Aug. 16, 2008

nospam@example.com (Patricia Walter) — Mon, 18 Aug 2008 15:10:48 -0700

Click here to view a Transcript of the Surface Hippy Chat with Dr. Bose on Aug. 16, 2008

First Zimmer Durom Hip Replacement Lawsuit Filed

nospam@example.com (Patricia Walter) — Tue, 12 Aug 2008 17:30:05 -0700

Link - Read Complete Article by Clicking Here

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.

Metal-on-Metal Hip Resurfacing Growing More Popular

nospam@example.com (Patricia Walter) — Fri, 08 Aug 2008 17:00:21 -0700

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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.

FDA wants surveillance net for orthopedic devices

nospam@example.com (Patricia Walter) — Mon, 04 Aug 2008 21:01:09 -0700

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.

Complaints Undermine Hip Device

nospam@example.com (Patricia Walter) — Fri, 25 Jul 2008 16:10:30 -0700

Read Original Link Here

By BARRY MEIER July 24, 2008

Zimmer Holdings, the nation’s biggest producer of orthopedic devices, says it will suspend sales of an artificial hip component that some doctors have complained was failing at a high rate.

The company also lowered its earnings outlook as a result of the suspension, and its shares fell sharply Wednesday.

In recent months, some doctors have complained that the device, a hip socket known as the Durom cup, was failing in their patients, who then had to undergo replacement surgery.

Zimmer said its investigation had determined that the product was not defective. But it stated that even some experienced surgeons had found it difficult to implant. The company said it expected to resume sales once specialized training for doctors had begun.

Since it was first sold in the United States in 2006, the Durom cup has been implanted in more than 12,000 patients. Zimmer said it expected the overall need for early replacement in patients would be low. But Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures in coming years.

Some doctors said their patients had not had problems with the cup.

The company also said the sales halt would cut $20 million to $30 million from its sales estimates. Zimmer said it expected that earnings for the year would be $4.05 to $4.10 a share, down from its earlier forecast of $4.20 to $4.25 a share.

In composite trading on the New York Stock Exchange, shares of Zimmer, which is based in Warsaw, Ind., fell $4.87 a share to close at $66.01 a share. Bruce Nudell, an analyst at UBS who covers medical devices, said that the company had not issued any warnings that sales would be halted.

“They had given hints that there would not be a recall but this came as a surprise,” Mr. Nudell said.

The issue with the device surfaced in April when a surgeon in Los Angeles, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures his patients were experiencing. In response, Zimmer said it would start an investigation but said it saw no reason to take added action like halting sales.

At the time, Zimmer also cited European data showing that the device was doing well there. But the version of the device used outside the United States is slightly different from the one used here. Also, while doctors here use it in traditional hip replacement, surgeons in other countries used it in a relatively new kind of hip surgery known as resurfacing, which involves somewhat different surgical techniques.

Zimmer, which announced the sales suspension late Tuesday, said that its investigation found that using the cup required a higher degree of precision.

Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it.

“It is a bad design,” he said.

Mr. Nudell, the analyst, said that other doctors were happy with the cup, but he expected that Zimmer might see a 50 percent drop in the product’s use when sales resumed.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the process that is used in Europe. That decision will put it further behind competitors that already have such products on the American market.

Zimmer Hip Issue Delays Resurfacing System, May Help Rivals

nospam@example.com (Patricia Walter) — Fri, 25 Jul 2008 16:00:37 -0700

July 23, 2008

Original Link - Click Here

Zimmer Holdings Inc.'s (ZMH) U.S. sales suspension for "Durom" replacement hip parts will further delay progress in bringing a bone-sparing hip system to the U.S. market, which could benefit smaller competitors.

Zimmer announced Tuesday that it has temporarily stopped selling Durom parts - which are cups used to make replacement hips - because U.S. surgeons need retraining to avoid problems. Since Durom is part of a so-called hip resurfacing system Zimmer is studying now, and hoped to bring to the U.S. in a few years, Zimmer also halted the U.S. resurfacing study. "We are suspending enrollment until further notice," said Cheryl R. Blanchard, senior vice president of research and development and chief scientific officer at Zimmer, during a conference call with analysts Wednesday.

Due to the Durom suspension, "there will be some delay beyond that 2011 period that we earlier referenced" for a hip-resurfacing rollout, added James T. Crines, Zimmer's chief financial officer.

By preserving bone for potential future surgeries, hip resurfacing is seen as a market-expanding technology that could bring younger patients into the nearly $5 billion global replacement hip market. Thomas Weisel analyst Raj Denhoy believes resurfacing sales could represent 10% of total replacement hip sales in the U.S. by 2012.

Smith & Nephew PLC (SNN) won Food and Drug Administration approval in May 2006 to bring the first modern resurfacing system to the U.S. Corin Group PLC ( CRG.LN), another U.K. firm, won FDA approval for its system last summer, but uptake has been slowed by issues at Stryker Corp. (SYK), which is marketing Corin's device in the U.S.

The Corin product slowdown has benefited Smith & Nephew, and signs that industry heavyweight Zimmer won't be marketing a competitive product as soon as hoped is another positive development.

Shares of Smith & Nephew, which Piper Jaffray upgraded to buy from neutral on Tuesday, recently traded up 1.4% to $57.74.
Zimmer officials did not estimate a new timeline for when a resurfacing system might roll out in the U.S. On the company's first-quarter earnings call in April, Crines said 2011 was the earliest date, following some other delays in the program. He also said that Zimmer's sales, marketing and product development efforts would remain focused on the other 90% of the replacement hip market in the near-term.

He reiterated that plan on Wednesday's call.

Wright Medical Group Inc. (WMGI) is another potential beneficiary from Zimmer's delay if it can finally secure approval for its resurfacing product. Wright has been in regulatory limbo at the FDA for years and hasn't explained the reason, although management has said the company still expects approval.

Wright has a better chance to capitalize in the near term by seeking to capture some lost Durom business from Zimmer, because Wright has similar technology. Shares of the company recently traded 3% higher to $31.10.

Zimmer shares, hurt by the Durom issue and a cut to 2008 guidance, recently traded down 5.5% to $66.94.

-By Jon Kamp, Dow Jones Newswires

Pseudotumours Risk For Hip Resurfacing

nospam@example.com (Patricia Walter) — Sat, 12 Jul 2008 09:25:13 -0700

Pseudotumours Risk For Hip Resurfacing Highlights Need For Regular Clinical Follow-up For New Devices

Link http://www.medicalnewstoday.com/articles/114601.php

July 11, 2008

As the incidence of metal-on-metal hip resurfacing has increased in recent years, especially in younger patients, research published in the Journal of Bone and Joint Surgery - British Volume (JBJS-Br) discusses occurrences of "pseudotumours" as a result.

The researchers estimate that approximately 1% of patients who have metal-on-metal hip resurfacings develop pseudotumours within five years of treatment. A pseudotumour is 'a soft-tissue mass associated with the implant…neither malignant nor infective in nature', but that causes pain and discomfort to the patient.

Most worryingly for patients and doctors is that the causes of the tumours are unknown. The research discusses possible causes including 'toxic reaction to an excess of particulate metal wear debris.' The article stresses the need for further research to be done into the incidence of pseudotumours in patients who have had this treatment.

The paper concludes that the incidence of pseudotumours must be related to metal-on-metal hip resurfacing highlighting 'the need for regular clinical follow-up for new devices'. Such follow-up would follow NICE recommendations, but the current NHS climate makes this difficult, if not impossible, to achieve.

Read the research abstract

Notes

- The Journal of Bone and Joint Surgery - British Volume is a world leading orthopaedics journal with an Impact Factor of 1.868

- JBJS-Br publishes twelve issues a year of high-quality, peer-reviewed research, overseen by an international editorial board led by Editor James Scott

- The Journal was first published in 1948 by The British Editorial Society of Bone and Joint Surgery, a registered charity (No. 209299), with the object of the advancement and improvement of education in orthopaedic surgery and allied branches of surgery and the diffusion of knowledge of new and improved methods of teaching and practicing orthopaedic surgery in all its branches

- You can find out more about the Journal at http://www.jbjs.org.uk

Journal of Bone and Joint Surgery, British Volume

Pseudotumours Risk For Hip Resurfacing Highlights Need For

nospam@example.com (Patricia Walter) — Sat, 12 Jul 2008 09:25:13 -0700

Link http://www.medicalnewstoday.com/articles/114601.php

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11, 2008

As the incidence of metal-on-metal hip resurfacing has increased in recent years, especially in younger patients, research published in the Journal of Bone and Joint Surgery - British Volume (JBJS-Br) discusses occurrences of "pseudotumours" as a result.

The researchers estimate that approximately 1% of patients who have metal-on-metal hip resurfacings develop pseudotumours within five years of treatment. A pseudotumour is 'a soft-tissue mass associated with the implant…neither malignant nor infective in nature', but that causes pain and discomfort to the patient.

Most worryingly for patients and doctors is that the causes of the tumours are unknown. The research discusses possible causes including 'toxic reaction to an excess of particulate metal wear debris.' The article stresses the need for further research to be done into the incidence of pseudotumours in patients who have had this treatment.

The paper concludes that the incidence of pseudotumours must be related to metal-on-metal hip resurfacing highlighting 'the need for regular clinical follow-up for new devices'. Such follow-up would follow NICE recommendations, but the current NHS climate makes this difficult, if not impossible, to achieve.

Read the research abstract

Notes

- The Journal of Bone and Joint Surgery - British Volume is a world leading orthopaedics journal with an Impact Factor of 1.868

- JBJS-Br publishes twelve issues a year of high-quality, peer-reviewed research, overseen by an international editorial board led by Editor James Scott

- The Journal was first published in 1948 by The British Editorial Society of Bone and Joint Surgery, a registered charity (No. 209299), with the object of the advancement and improvement of education in orthopaedic surgery and allied branches of surgery and the diffusion of knowledge of new and improved methods of teaching and practicing orthopaedic surgery in all its branches

- You can find out more about the Journal at http://www.jbjs.org.uk

Journal of Bone and Joint Surgery, British Volume

Transcript of Dr. Mont Live Chat July 16, 2008

nospam@example.com (Patricia Walter) — Tue, 08 Jul 2008 12:18:02 -0700

Read the transcript of the questions and answers from the Dr. Mont Chat on July 16