Surgeon Says Recalled Stryker Metal Hip Implant May Fail Half the Time

April 4, 2013 By Lillian Chan

Overview: Litigation and safety concerns have been mounting over the Stryker Rejuvenate and ABG II Modular-Neck hip stems since they were recalled in July 2012. The metal-on-metal hip implants were recalled due to a risk of corrosion, which has been a concern with other devices in the same class. Dr. Zann, an orthopedic surgeon who has implanted 400 of the implants, tells The Palm Beach Post that he fears revision rates may be as high as 50 percent since it came onto the market in 2009.

Stryker Rejuvenate and ABG II Modular-Neck hip stems were recalled in July 2012 due to a risk of corrosion

A Florida surgeon says he fears revision rates may be as high as 50 percent; he has removed 100 failed hip implants

The recalled hip implants are metal-on-metal devices, which have come under scrutiny due to reports of high failure rates

Product:  ABG II Modular Femoral Stem and Modular Neck system

Manufacturer: Stryker

Side Effects & Complications

• High failure rate
• Necrosis (tissue death)
• Increased levels of cobalt and chromium ions
• Pain at the implant, sometimes spreading to the groin and back
• Osteolysis (bone loss)
• Fluid collections/solid masses around the hip joint

“Wearing Us Down”

Dr. Zann told the Palm Beach Post that he has implanted 400 recalled hip implants in total and has removed 100 failed Stryker hip implants within the past year. He said that since then, he has seen patients young and old suffer from metal contamination and painful, fluid-filled tumors surrounding the hip joints. “When I start operating it is the same mess in them, every single one,” he stated. He consistently finds a high-pressure fibrous tumor-like pocket so full of liquid that pops when he cuts it, according to Palm Beach Post. The so-called revision surgery is difficult for both the surgeon and the patient. “We are exhausted right now. This is wearing us down. This is really wearing us down.” Zann says that revised hips often perform worse than the initial hip implant because the bone loss causes issues with fit.

Stryker Rejuvenate ABGII Recall Hip Implant Lawsuits

In July 2012, Stryker Orthopedics recalled the Rejuvenate and ABG II systems due to a risk of corrosion and fretting at the modular-neck junction. The company is recommending that all patients implanted with the recalled device to undergo metal ion testing and diagnostic imaging to detect potential complications. Court records show that at least 81 lawsuits have been filed over the metal-on-metal hip implants.

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• Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick… (earlsview.com)
• Stryker Rejuvenate Hip Recall Lawsuit News: Updated Information for Stryker Hip Implant Recall Lawsuits In State & Federal Courts, Provided By Alonso Krangle LLP (prweb.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
• Stryker Rejuvenate and ABG II Hip Stem Problems Addressed in Multi County Litigation (MCL), Patients Urged to Contact Attorney Fred Pritzker (prweb.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
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• RLG Responds to Report of Higher Metal-on-Metal Hip Replacement Failure Rates in Women (earlsview.com)

Source – Connie; My DePuy Hip Recall

Acta Orthop. 2008 Dec;79(6):734-47.

Polyethylene particles have been shown to elicit a foreign-body, granulomatous (mass of immune cells that forms when the immune system attempts to wall off substances that it perceives as foreign but is unable to eliminate like metal)  response stimulating infection, which consists mostly of :

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This was the first time I had met the private orthopaedic surgeon and I was very pleasantly surprised at his openness, approachability and professionalism.

We reviewed my X-rays and confirmed the osteolysis and bone loss. The health of the bone at the top of the femur is a concern and I am going to have a nuclear medicine bone scan tomorrow morning to see what is going on with the blood flow to and around the bone.

I had a biopsy taken later in the day at the hospital and there was not much in the way of fluid – more a greyish fibrous capsular type of tissue – now with the pathologist.

The movement of the prosthesis, or lines suggesting movement within the femur where obvious (it seems?).

Regardless, the hip pops and clicks in and around audibly a few dozen times a day as I move, standing and sitting.

So – bottom line, for whatever reasons, this hip is not performing and so the surgeon is intending to remove it in a few weeks and put a lovely Smith & Nephew Ceramic on Ceramic hip in its place.

This is from the Smith & Nephew website:

It is the 99% ceramic in ceramic that is going to do the job…

They go on to say:

Ceramic on ceramic

Another option for extending the life of your hip replacement is ceramic on ceramic. These implants reduce wear by 99%³ in laboratory testing when compared to traditional metal on plastic. With ceramic on ceramic hip replacements, both the ball and socket are replaced with ceramic. These implants have an excellent reputation for reducing wear, but have limited flexibility in design options due to manufacturing limitations of the ceramic material. Therefore these implants are not suited for all patients. Talk with your surgeon about this technology and if it is right for you.

Not a Small Job…

It is going to the a biggish operation as the press-fit acetabular cup will have to come out and a bone graft will be required to fit the new cup plus a few trusty screws...

And then he will need to dig out the femoral implant but the way it looks that should come out very easily – but he will then have to dig out the old cement and the cement that spewed down the femur when the last surgeon did not use a glue cup.

A longer femoral stem will be required and he may get away with a press fit – time will tell.

Bone Scan

So tomorrow – bone scan and then back to see the surgeon Thursday 28th July….

Will keep you posted.

Cheers

Earl

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• Ceramic Hip Replacement (earlsview.com)
• History – Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip (earlsview.com)
• Options for Hip Replacements – different materials (earlsview.com)
• Ceramic-on-Ceramic Hip Implant Let Patients Stay Active Longer (earlsview.com)
• How Long Do Hip Replacements Last? (earlsview.com)
• Mr. Michael Solomon, Sydney Australia Surgeon Gives Advice on Hip Replacement (earlsview.com)

J. Cooper Carlisle | July 2nd, 2011 | Posted in Depuy Hip Recall News

DePuy Orthopaedics is moving into battle with a new leader at its helm following a major DePuy hip recall and a wave of litigation against one of the largest orthopedic device manufacturers in the world.

New president Andrew Ekdahl was appointed earlier this year to replace David Floyd, who resigned in February amid a swirl of litigation and regulatory scrutiny over the DePuy ASR and Pinnacle hip systems.

DePuy Hip recall in August 2010

Last August, the FDA issued a DePuy hip recall for more than 93,000 ASR systems implanted across the globe, after the device was found to fail prematurely in 12 percent of ASR recipients. More recent studies suggest failure rates could be as high as 49 percent over 6 years.

Today, thousands of ASR recipients have filed a DePuy ASR hip lawsuit against the company, with claims ranging from negligence to fraud.

DePuy Pinnacle Hip lawsuit as new president takes over

Ekdahl enters the fray as a separate hip system comes under scrutiny. In May 2011, a high-ranking judicial panel approved of consolidating lawsuits over the Pinnacle, an older metal-on-metal hip replacement system implicated in complications similar to those found with the ASR. The Pinnacle is a predicate device of the ASR – it’s observed safety was instrumental in the ASR’s clearance by the FDA. People who have received the Pinnacle system may file a Pinnacle hip lawsuit through the US District Court for the Northern District of Texas.

New president may be just the man to handle DePuy Hip lawsuits

People close with Ekdahl believe he is cut out for the job. He has been with DePuy and parent company Johnson & Johnson for more than twenty years, most recently serving as franchise vice president of DePuy Europe, Middle East and Africa.

“There’s no doubt (Ekdahl) is coming into a crappy situation,” Robin Young, founder of orthopedic-data firm PearDiver Technologies tells the Ft. Wayne, Indiana Journal Gazette. “But I’m sure he was selected based on experience.

The full extent of the “crappy situation” may come to light as DePuy Orthopedics complies with an FDA request to deliver post-market performance data on the metal-on-metal hip replacement systems it has put into commerce. The results could be delivered later this year.

It remains to be seen if any models other than the ASR become implicated in a DePuy hip recall or if new systems become named in lawsuits. It is tough to see the situation becoming more difficult for the company than it already is.

Technorati Tags: FDA, bad hip, Chrome Poisoning, cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip Replacement System, DePuy Hip Replacement, DePuy Hip Replacement Recall, DePuy Lawsuit, Dislocation, hip recall, Hip Replacement, Hip Revisions, metal on metal hip, Zimmer Hip Replacement

Posted on July 1, 2011 by Los Angeles Criminal Defense Lawyer Site

Concerned parties for the DePuy hip recall mass litigation are preparing themselves for a hearing scheduled this November 18. A move to centralize and condense the multiple lawsuits filed against the orthopedic manufacturer will be decided upon by a panel of seven federal judges known as the Judicial Panel. The Panel will meet at Duke School of Law situated in Durham, North Carolina and will give approval for a Multidistrict Litigation (MDL) as they see fit.

DePuy Orthopaedics manufactured two hip replacement devices known as the ASR XL Acetabular System and the ASR Hip Resurfacing System. In a British study, these implants were found to have a 12 percent failure rate, a rate alarmingly high than the industry average of 5 percent. The implication being, 1 of 8 recipients of the ASR units would need revision surgery within 5 years. Reports of swelling, pain and stiffness were noted.

Recipients overseas hearing about the DePuy hip replacement recall have also surfaced to claim compensation for damages brought about by the DePuy hip implants. This case has gone global as the DePuy hip implants were also sold in Australia, UK and Ireland. Globally, approximately 93,000 hip devices were recalled. In the United States alone, hundreds of lawsuits have already been filed.

The decision to choose what district the case’s jurisdiction falls under would be made once the MDL is approved by the Panel. Currently, some districts that are covered by the lawsuit include the District of New Jersey, the Central District of California, and the Northern District of Illinois. There has been a suggestion that the case would be put under Judge Susan D. Wigenton in the District of new Jersey but DePuy claims it to be unsuitable since Judge Wigenton is also looking over a similar case with Zimmer Holding, Inc. They suggested to transfer it either to the District of Ohio or the Northern District of Indiana instead for it to be nearer their headquarters situated in Warsaw, Indiana.

An estimated total of 4,000 lawsuits are expected by legal experts to be filed as more hip recall victims are coming forth. If you are one of those who has had a DePuy ASR implanted, have yourself evaluated by your doctor. He could specify if anything is amiss with your implant. There are a lot of options a hip recall recipient is entitled to take and a hip replacement lawyer can help you discuss them.

Technorati Tags: FDA, bad hip, Chrome Poisoning, cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip Replacement System, DePuy Hip Replacement, DePuy Hip Replacement Recall, DePuy Lawsuit, Dislocation, hip recall, Hip Replacement, Hip Revisions, metal on metal hip, Zimmer Hip Replacement

Contact Website: http://www.depuy-lawyers.com/Lawyers Represent People Harmed by DePuy ASR Hip Implant

O’Steen & Harrison Files Lawsuit On Behalf of Arizona Woman Injured by Defective DePuy Hip Replacement

January 25, 2011—Jacqueline Chamberlin filed a lawsuit against Johnson & Johnson and its subsidiary DePuy Orthopaedics in Superior Court in San Francisco, California. The lawsuit alleges that the manufacturers sold the ASR™ XL Acetabular System for more than five years, while receiving and concealing repeated warnings of aberrantly high failure rates.

Last August, DePuy voluntarily recalled its ASR™ XL Acetabular System hip replacement after a report published in the United Kingdom revealed that an abnormally large number of patients needed corrective surgery within five years of implantation.

We encourage you to learn more about the lawsuit against DePuy Orthopaedics and Johnson & Johnson.

Johnson & Johnson Announces Recall of Defective DePuy ASR Hip Replacement

August 24, 2010—Johnson & Johnson’s joint replacement business, DePuy Orthopaedics, Inc., announced a voluntary recall of its ASR™ XL Acetabular System hip replacement following a report published in Great Britain which revealed that about one in every eight patients required corrective surgery within five years of implantation. Specifically, the revision rate for the ASR™ Hip Resurfacing System is 12 percent and for the ASR™ XL Acetabular System is 13 percent.

Since early 2008, the Federal Food and Drug Administration (FDA) has received hundreds of complaints about DePuy ASR™ Implants. Most of these patients required removal and replacement of the devices following their implantation.

Orthopedic experts say the problem with the DePuy implant rests primarily in the design of the ASR™ hip replacement cup. It is more shallow that other hip replacement devices. In addition the ASR™ cup has been found to be more difficult for surgeons to implant at the proper angle.

Because the DePuy Implants are metal-on-metal total hip replacement units, they can produce metallic particles as they age and wear. The result in some patients is severe inflammatory reaction which may damage surrounding soft tissue.

Both DePuy hip replacement devices were implanted in patients between 2003 and 2009, when Johnson & Johnson ceased production of them. More than 90,000 DePuy hip implants were sold worldwide before production was discontinued. Based on the documented failure rates for the devices, it is anticipated as many as 11,000 patients will eventually require painful and disabling hip replacement surgeries to remove the defective DePuy implants and replace them with other units. Many patients who received the ASR™ hip implants are likely to eventually require explanation of the devices even though they are presently symptom free. All patients with these DePuy implants are encouraged to promptly consult their physicians for evaluation and to arrange for future monitoring.

In connection with the recall, DePuy announced it will reimburse implant patients for reasonable medical expenses, but only if they sign medical release forms giving the company broad access to their personal and otherwise private medical records. Furthermore, these reimbursements are greatly limited in that they extend only to out-of-pocket costs that are not covered by the patient’s medical insurance. There is no compensation for pain and suffering, disability, nerve or tissue damage or any loss of income associated with the defective DePuy hip implants.

For these reasons, we encourage all DePuy hip replacement patients to consult with a lawyer who is experienced in dangerous medical device litigation before attempting to deal directly with DePuy or Johnson & Johnson.

What You Should Do

Your Health

If you have a DePuy ASR hip device, promptly consult your physician for an evaluation.

Your Legal Rights

If you have received a DePuy ASR hip device, you may be entitled to compensation. You should act immediately to contact a lawyer experienced in matters involving defective medical devices.

Our DePuy Lawyers Can Help

O’Steen & Harrison, PLC presently is handling legal claims on behalf of those harmed by the DePuy ASR hip replacement system. We invite you to contact us for a free, confidential consultation about your legal rights.We will represent patients throughout the United States. We can help you, too, wherever you live.For free answers to your questions about how our lawyers can help if you have been harmed by a defective DePuy ASR hip replacement, please call us toll-free at 1-800-883-8888 or complete this online contact form.

Technorati Tags: FDA, bad hip, Chrome Poisoning, cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip Replacement System, DePuy Hip Replacement, DePuy Hip Replacement Recall, DePuy Lawsuit, Dislocation, hip recall, Hip Replacement, Hip Revisions, metal on metal hip, Zimmer Hip Replacement

Hi Earl,

This is Juergen, Toni’s husband. Sorry to hear about your story -better nightmare-. I can relate to what you are going through. Similar to your surgeon, mine was even downplaying any issue with elevated toxic metal levels (my cobalt and chromium levels are 200 times higher than normal). So much more to tell. I’ll attach a word file that includes ‘Calendar of events’.

It would be great when you publish it on your blog. We have nothing to lose anymore as I am not just a cripple, also out of all funds, savings, hoping that I will be granted SSA Disability later this year, and also hoping that Ed Blizzard Law Firm (he is not just a great guy, he also was one of the lead attorneys in the Vioxx case against Merck Pharma with a verdict of almost 5 billion dollars) will take on the case.

All my compliments on your website and blog.

Regards,

Juergen

NOTE: Here is Information in Ed Blizzard from the Web:

Ed Blizzard

Houston, Texas
Phone        713-844-3750
Toll-free     1-800-349-0127
Fax             713-844-3755

Contact us for a free case review

Ed is originally from Chester, Pennsylvania. His family moved to Texas in 1971 shortly after he graduated from high school. At the University of Texas at Austin, Ed excelled at his undergraduate studies, graduating with honors. Ed earned his law degree from Baylor University School of Law, graduating cum laude and garnering several awards, including American Jurisprudence Awards for Property, Federal Courts, Administrative Law, Property and Practice Court. Additionally, Ed was inducted into the Order of the Barristers, one of the most prestigious legal honor societies. During law school, Ed perfected his trial advocacy skills as a member of the Baylor mock trial team. Ed’s exceptional oratory skills allowed him to excel in several competitions, including as a finalist in Baylor Law School Mock Trial Competition.

Ed founded Blizzard, McCarthy & Nabers in 1981 after working for three years as a litigator at Fulbright & Jaworski, L.L.P- a well-known nationwide litigation firm. Over the past 25 years, Ed has been a part of some of the largest pharmaceutical injury verdicts and settlements in the country. Not only has Ed helped obtain 9 billion dollars in settlements and verdicts for thousands of clients, but he has also become a leader in mass tort litigation. Some of Ed’s leadership roles include:

• Appointed to six member Negotiating Plaintiff’s Committee (NPC) in Vioxx MDL 1657 and helped negotiate a 4.85 billion dollar settlement
• Member of the Fee Allocation Committee in the Vioxx MDL 1657
• Served as the chair of the Plaintiff’s Steering Committee in Ephedra Litigation, MDL 1598
• One of five lawyers appointed to negotiate Sulzer Hip Implant Litigation MDL 1401
• Member of Steering Committee in the Diet Drug Litigation, MDL 1203
• Member of Texas Steering Committee in Silicone Breast Implant Litigation
• One of the chief negotiators of the $3 billion Dow Corning settlement
• Appointed to the State Liaison Committee in the Baycol Proceedings
• Member of Plaintiff’s Steering Committee in the New York ReNu and MoistureLoc proceedings
• Member of Plaintiff’s Steering Committee in Digitek Litigation MDL 1968

Ed’s leadership role in mass tort litigation has prompted his participation as a frequent speaker at continuing legal education seminars where he teaches other practicing attorneys about mass tort litigation. Some of the recent notable classes and seminars that Ed has taught include:

• Deconstructing the U.S. Supreme Court’s Decision on Preemption in Wyeth v. Levine (2009 AAJ Teleseminar)
• Vioxx: An Overview and Maneuvering Through the Settlement Process (2008 AAJ San Juan Winter Convention)
• “Hot Topics in Pharmaceutical & Medical Device Litigation”, (2008 AAJ Faculty Seminar)
• “Pushing Cases in Litigation to Achieve Resolution”, (AAJ June 2008)
• “Winning in Depositions: Victory through Killer Depositions, (AAJ February 2008)

As one of the most prominent Pharmaceutical litigation attorneys in the country, Ed has won several awards including the Clarence Darrow Award, Top 100 Lawyers in Texas, Super Lawyers, Million Dollar Advocates Forum, Multi-Million Dollar Advocates Forum and The Best Lawyers in America 2007 and 2011 in the field of Personal Injury Litigation.

Ed’s significant verdicts and success has garnered widespread media attention from prominent media outlets such as, The New York Times, The Wall Street Journal, Bloomberg and ABC News. Additionally, Ed has made several television appearances including A Current Affair, MSNBC‘s Squawk Box and CNN Financial News.

Ed is married to his college sweetheart, Cindy, and they have a lovely daughter, Anna, who is the pride and joy of their life together. In his spare time, Ed loves to play golf.

Technorati Tags: FDA, bad hip, Chrome Poisoning, cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip Replacement System, DePuy Hip Replacement, DePuy Hip Replacement Recall, DePuy Lawsuit, Dislocation, hip recall, Hip Replacement, Hip Revisions, metal on metal hip, Zimmer Hip Replacement

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By BARRY MEIER

Published: June 25, 2011, New York Times

IT is an American impulse to covet the new and improved — whether it’s a faster computer, a smarter cellphone or a more fuel-efficient car. And in medicine, too, new drugs, devices and procedures have advanced patient care.

Gary Neill

But the promise of innovation can also prove a trap, a situation now playing out with dire consequences for possibly tens of thousands of people who received artificial hips intended to let them remain active. The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear. In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold. A review of the medical world’s embrace of the metal-on-metal hips over the past decade — including interviews with doctors, industry consultants, regulators, medical experts and patients — shows how innovation’s lure led almost everyone to seize on a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options. “As a non-American, I don’t completely understand it, but there is a phenomenon in the U.S., the latest and the greatest,” said Dr. Henrik Malchau, who practiced as an orthopedic surgeon in Sweden before going to Massachusetts General Hospital in Boston. “There was a patient demand to get these implants on the misconception that the latest was the best.” For many manufacturers, the constant churning of new products can be a business necessity, a way to gain an edge on competitors while maintaining or even raising prices. But in recent years, a host of supposed innovations have imploded not long after introduction.

Several heavily promoted artificial spinal disks, claimed by their makers to be major innovations, proved no better than previous ones. After the blockbuster diabetes drug Avandia was linked to heart attacks, a federal study concluded that older drugs were safer and worked better for most patients. And a new heart device component from Medtronic started fracturing after it was implanted in more than 200,000 patients; at least 12 people died in connection with that product. Some experts, like Dr. Malchau, said they used a special type of metal-on-metal implant known as a resurfacing device in specific patients — mainly taller, middle-age men — because data showed that they worked in that small group. But as with many innovations, metal hips were marketed to all comers. For example, about 65 percent of the implants went to women and older patients, according to an estimate by a consulting firm, Exponent Inc. As it turned out, those two groups appear most prone to failures involving the devices. “The vast majority of the ‘innovations’ on which we have spent money with respect to orthopedics over the past two decades have not resulted in improved patient outcomes,” said Dr. Kevin J. Bozic, an orthopedic surgeon and professor at the University of California, San Francisco, who has written about artificial joints’ impact on health care costs.

Last year, DePuy, the orthopedics division of Johnson & Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom.  DePuy, Zimmer and other companies and doctors have said that most patients who received metal hips have done well. Experts like Dr. Bozic suggest that big gambles on innovation are justified in dealing with diseases, like some cancers, where current treatments are ineffective. But they say that calculus should shift sharply when existing treatments are highly effective, and that doctors need to use better yardsticks before embracing new technologies in those cases or adopt changes slowly.

THE modern artificial hip, which was developed by a British surgeon, Dr. John Charnley, in the 1960s, uses a relatively simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients. Metal-on-metal implants, in which the cup is also made of a metal alloy, had been tried during those early decades, but were largely abandoned after tests found that patients had metal particles in their blood or organs, raising concerns about long-term health risks like cancer. By 1996, Jonathan Black, an industry consultant and professor emeritus of bioengineering at Clemson University, warned in a medical journal article that the metal-on-metal design posed significant risks because little was known about the biological havoc that metallic debris might cause. He also argued that given the high success rate of existing designs, it would be statistically impossible to run enough studies to prove the new implants’ supposed superiority. At the time, Mr. Black estimates, the all-metal implants accounted for only a tiny fraction of some 250,000 hips implanted annually in the United States. By 2008, they were used in one out of every three hip procedures.

What happened? In essence, the old technology was repackaged as new and cutting-edge, and warnings like Mr. Black’s were ignored and considered no longer relevant. This new generation of devices was manufactured differently and reflected better designs, advocates argued. Companies and surgeons began promoting the new implants as the next big step in orthopedics, one that would let patients, particularly middle-age ones, do strenuous physical activities because their mechanics were more natural. And patients, intrigued by ads featuring celebrity athletes, also wanted such devices.

C.J. Gunther for The New York Times Kathleen Herlihy-Paoli, above at Marblehead, Mass., received two all-metal artificial hips two years ago.

“I was a skier and a hiker,” said Kathleen Herlihy-Paoli, 55, a graphic designer in Missoula, Mont., who had both of her arthritic hips replaced two years ago with all-metal devices. “My doctors said these would last longer and enable more activity.”

For physicians, new products like the all-metal hips have several attractions, experts say. Along with the potential to improve care, new technology gives the doctor offering it a way to market his or her practice as different from that of a competitor. An orthopedic surgeon in Los Gatos, Calif., Dr. Edward Littlejohn, was one of the hundreds of physicians nationwide who started implanting the all-metal devices soon after they were marketed. Dr. Littlejohn said he had long used implants made by DePuy, and believed the new all-metal devices were safe because they had passed F.D.A. muster. “I was a DePuy guy,” he explained. Things started out great, he said. But about a year and some 40 implants later, patients started complaining of pain. One woman developed a condition that Dr. Littlejohn had rarely seen before: a buildup of gray-colored fluid around her hip. It was about then, Dr. Littlejohn said, that he realized he had leapt too soon. “It has not been fun,” he said.

Dr. Lawrence Dorr, a surgeon in Los Angeles who helped popularize all-metal hips, said they also appealed to doctors for a practical reason: they reduced the risk that a new hip would dislocate soon after implantation. By using a metal cup, which is thinner than a plastic one, a surgeon could implant a bigger ball component, Dr. Dorr explained, which was less likely to dislocate than a smaller one. Recent research, however, suggests that such oversized components may be a part of the reason the devices shed metallic debris. “I thought this could be a home run,” Dr. Dorr recalled. “Instead, it turned out to be a strikeout.”

There were skeptics along the way, like Nadim J. Hallab, an implants expert at Rush University Medical Center in Chicago. Dr. Hallab worked with surgeons who were disappointed with the earlier generation of all-metal devices, and they remained skeptical about the new ones. “I never thought this was going to fly,” he says. But it was an about-face by Dr. Dorr in Los Angeles, that first sounded a public alarm. In 2007, he alerted fellow surgeons after some of his patients developed pain and had to have replacement operations. As the number of affected patients nationwide mounted, it emerged that the devices shared a trait with other failed innovations: most of them had been little tested.

UNDER F.D.A. rules, most all-metal hips don’t have to undergo clinical trials before sale. Instead, they are tested in labs on machines that simulate millions of steps to study the forces exerted by years of motion. Such wear is inevitable in an artificial hip; for example, tests showed that the type of plastic used in some plastic-metal hips shed particles that led to bone loss in some patients. Similar tests of the all-metal implants did not point to problems, testing experts say. But in retrospect, they added, they think they understand why: the simulations were apparently based on idealized conditions, not on what would happen in the real world of doctors and patients. For example, all-metal devices proved less forgiving than metal-and-plastic ones to small variations in how they were implanted, with components sometimes striking together and generating debris.

Monica Almeida/The New York Times Harry McKellop is a device testing expert at Los Angeles Orthopaedic Hospital.

Harry McKellop, a device testing expert at Los Angeles Orthopaedic Hospital, said it was his understanding that “most of the early metal-on-metal testing was not done under adverse conditions.” While some metal implants have performed well in certain patients, the devices, as a group, are twice as likely as metal-and-plastic ones to require early replacement, according to data from Australia’s orthopedic registry, one of the most comprehensive databases on implants. Most troublingly, damage from debris generated by metal implants is proving far more insidious than that caused by plastic particles. In some patients, it has caused crippling tissue and muscle damage, and has produced neurological problems in others.

The innovation cycle involving the hips has now entered a new phase: cleanup. Regulators, researchers and companies must assess the damage caused, and determine how to undo it. ACCORDING to one estimate, about 500,000 patients in the United States may have gotten an all-metal hip in the past decade, raising the likelihood that tens of thousands will have painful early-replacement procedures. Even if the share of seriously injured patients stays low, as researchers hope, thousands are likely to be affected, experts estimate.

In early May, orthopedic specialists and company officials discussed how best to perform the special studies the F.D.A. is now requiring. Pitfalls may abound, specialists warned. For example, only certain labs are authorized to measure metallic ions in the blood, and diagnostic equipment, unless specifically calibrated, will not detect tissue damage. There may also be some confusion about the advice coming from the F.D.A. and other authorities. Officials urge patients to contact their doctors if they experience pain, but internal damage may be occurring in some patients who are free of symptoms. Ms. Herlihy-Paoli, the graphic designer, said her brother-in-law, a lawyer, urged her last year to get a blood test because he had a client with a failed metal hip. She said she thought it unnecessary because she felt fine, but when she did take the test it showed high levels of metallic ions. Feeling panicked, she sought out Dr. Malchau in Boston, who discovered that debris had already started a reaction around one implant that was producing aberrant tissue growth. “I had a tumor growing there,” Ms. Herlihy-Paoli said. “If I had left the hip in, it would have started damaging the bone and muscle.”

Needless to say, surgeons, testing experts, implant company officials and regulators are all eager to find a way to prevent such problems with other new devices. The proposals include better pre-market testing, consistent product tracking and phased-in introductions of new products. But many experts also want to ensure that too much second-guessing does not slow real innovation. Ultimately, the resolution of that quandary, some experts believe, may lie as much with the attitudes of doctors and patients as it does with regulation. Meanwhile, some participants in this long arc of events have also come full circle. For example, Mr. Black, the consultant who warned about use of all-metal hips, was hired not long ago by DePuy to advise it in connection with the scores of patient lawsuits pending against it. Mr. Black said he anticipates that lawsuits against it and other makers of all-metal hips may emerge as the largest product liability cases of this decade.

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R. M. Urban and J. J. Jacobs (download paper here)

Total hip and knee replacement prostheses generate wear and corrosion products at their bearing surfaces, at modular junctions, and at interfaces with cement or bone.

• Large numbers of these particles result in the formation of foreign-body granulation tissue, osteolysis and, in some cases, aseptic loosening requiring revision of the hip or knee.
• The potential immunologic problems and the possible systemic effects of widespread dissemination of metallic and polymeric degradation products are not well understood – but there are plenty of clues!
• In the vast majority of patients, permanent metallic orthopaedic implants are biocompatible and will continue to be used by orthopaedic surgeons.
• When applied appropriately, these devices have had a history of success with few serious short and long-term problems.
• However, in certain situations and in particular individuals, adverse biological effects may occur which can compromise the clinical outcome.

My view:

This paper is another from a Symposia series – good reading and theme is much the same as most papers – cobalt chrome DOES corrode in hip and knee replacements and this affects some people and not others. Other Papers from the Symposia Series:

• Alternative Bearing Surfaces

• Metal Ion Hypersensitivity in Metal-on-Metal Hip Arthroplasty

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Y.-S. Park, Y.-W. Moon and S.-J. Lim Download here

Total hip arthroplasty with use of metal-on-metal bearings has been reintroduced as an alternative to metal-on-polyethylene bearings because of theoretical advantages such as reduced wear and a lower prevalence of osteolysis. However, we have observed early osteolysis in nine patients (ten hips) out of 165 patients (169 hips) who had been managed with total hip replacements using a contemporary metal-on-metal hip design and investigated the possible etiologic role of metal hypersensitivity.

The nine patients who had an osteolytic lesion had a significantly higher prevalence of hypersensitivity to cobalt, as determined by patch testing, when compared to nine controls (p = 0.031). The retrieved periprosthetic tissues from the two revised hips showed no evidence of metallic staining, but microscopic analysis revealed a perivascular accumulation of CD3-positive T-cells and CD68-positive macrophages, and an absence of both particle-laden macrophages and polymorphonuclear cells.

Immunohistochemical analysis demonstrated that potent bone-resorbing cytokines such as IL-1β and TNF-α were produced mainly by infiltrated lymphocytes and activated macrophages.

These findings raise the possibility that early osteolysis in this second-generation metal-on-metal hip replacement is associated with abnormalities consistent with delayed-type hypersensitivity to metal.

In conclusion, our findings raise the possibility that early osteolysis in patients with this second-generation metal-on-metal hip replacement is associated with a delayed-type hypersensitivity to metal, mainly cobalt. As a result of our findings, we are reluctant to implant modern metal-on-metal bearings in patients who have a history of allergic reaction to a metal implant or metallic wear.

Technorati Tags: Chrome Poisoning , Cobalt Poisoning, Hip Replacement, Metal Ions, Cobalt Ions, Metal Hypersensitity

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