The Challenge of Corrosion in Orthopaedic Implants

Kenneth L. Urish, MD, PhD; Paul A. Anderson, MD; William M. Mihalko, MD, PhD; and the AAOS Biomedical Engineering Committee

Corrosion has been a persistent challenge in orthopaedics. Even Sir John Charnley noted the critical challenges of corrosion in the design of trauma and arthroplasty implants. The idea that different metals cannot be used in the same implant secondary to galvanic corrosion is a basic scientific concept in orthopaedic residency education.

But in actual practice, multiple different metals are combined to improve overall implant design. In hip arthroplasty, for example, cobalt-chrome heads fitted to titanium stems are the industry standard. Where is the disconnect between standard practice and textbooks?

Galvanic corrosion

Galvanic corrosion is the electrochemical potential difference between two dissimilar metals. In theory, one metal becomes the anode and the other the cathode. The active metal, the anode, is under attack from the more resistant metal, resulting in the corrosion. Given this basic knowledge that a circuit established between two different metals leads to aggressive corrosion, common sense would dictate not using multiple metals in an orthopaedic implant.

The passivation layer is the essential component that enables implants composed of multiple alloys to avoid galvanic corrosion. Metals are not inert. Oxide layers that develop in vivo or as a consequence of surface treatments protect implants from corrosion. In essence, the metal oxide film becomes an insulator, protecting the metal from direct exposure with the electrochemical milieu.

Not all metals can form a stable passivation film. Classic stable “passive” metals include titanium, chromium, and molybdenum alloys.

Corrosion in orthopaedic implants is really about the breakdown of this passivation film. Chemistry and mechanical wear erode the dynamic oxide film that insulates the implant and are key to both wear and corrosion. In essence, wear and corrosion become intertwined, each dependent on the other, and accelerate component breakdown.

Passivation layers

Passivation layer dynamics is the key concept behind three types of corrosion: pitting, crevice, and fretting. In pitting, localized dissolution of the metal oxide film and formation of cavities occur at rates faster than the build-up of the metal oxide layer. Crevice corrosion is based on a similar mechanism, but occurs in stagnant areas where fluid diffusion is limited.

In crevice corrosion, an increase in the concentration of chloride ions, low pH, and low oxygen tension accelerates breakdown of the passivation layer by creating conditions that increase the solubility of the metal oxide film. Fretting is mechanically assisted crevice corrosion, in which mechanical destruction of the passive film allows crevice corrosion to predominate. The combination with the highest potential for corrosion is stainless steel and cobalt-chrome; this combination has the weakest passivation layer, resulting in a lower threshold for corrosion.

Galvanic corrosion can potentially be avoided when a stable passive film develops on metal components and motion and local chemistry that can cause crevice and fretting wear are eliminated. When these criteria—a stable passive layer and elimination of motion between metals—are met, different metal alloys can be used in the same implant.

Hip arthroplasty implants

A classic example of mixing metals can be seen in total hip arthroplasty (THA) designs. Mixing metals first became advantageous after the introduction of porous-coated cementless arthroplasty components, such as the Harris-Galante, porous coated anatomic (PCA), and anatomic medullary locking (AML®) designs, which required metal alloys that provided a good bearing surface and were optimized for bone ingrowth.

Initially, the components in these models were either entirely cobalt-chrome or a mix of titanium alloy and cobalt-chrome. After early studies reported initial outcomes of hip pain and expressed concern about the high stiffness of cobalt-chrome femoral stems, the standard shifted to a cobalt-chrome head and a titanium alloy femoral stem.

What motivated the need for multiple material composition of the THA femoral component? Cobalt-chrome is an excellent material for the design of a femoral head. Its hardness is ideal for decreasing wear as a bearing surface. It is not as ideal for a femoral stem, given its significantly higher modulus of elasticity compared to bone.

Titanium alloys, on the other hand, are better as femoral stem components because they allow more bone ingrowth and have a closer modulus of elasticity to bone, resulting in less stress shielding of the implant. Titanium is also more biocompatible, fatigue-resistant, and easier (from a manufacturing perspective) to shape with the necessary geometry and substrate to encourage bone ingrowth.

The crucial connection for these two components occurs at the modular taper interface between the femoral head and neck. The taper essentially locks the head onto the neck. Friction prevents movement, but the junction is not impervious to fluid. These modular junctions can become the weak point in arthroplasty design, susceptible to wear and breakdown.

Multiple studies have demonstrated that crevice and fretting corrosion (ie, mechanically assisted crevice corrosion)—not galvanic corrosion—are the dominant modes of corrosion of the passivation layer at the head-neck taper interface. Even without galvanic corrosion, however, the corrosion can still be significant.

Mechanically assisted crevice corrosion can lead to numerous problems, including implant failure from loss of mechanical integrity, third-body wear due to trapped particles between the articulating surfaces, osteolysis, and localized granulomatous reactions. Recent reports of pseudotumor formation in well-fixed metal-on-polyethylene hip implants are likely the result of mechanically assisted crevice corrosion.

Fretting corrosion can be increased in a large metal-on-metal head due to the greater surface area of the bearing and the increased forces across the taper junction. When modularity is introduced at the neck, adding another taper junction, the debris from fretting corrosion can increase significantly (Fig. 1).

Corrosion continues to be a problem in orthopaedic implant despite more than four decades of experience. The passivation layer prevented initial fears of galvanic corrosion between certain pairs of mixed metals from occurring, but fretting corrosion is a major contributor to debris in many newer designs. When the correct criteria are met, crevice corrosion and fretting can lead to early implant failure. All surgeons should be cautious when adding levels of modularity that can add more debris to an implant system.

Drs. Urish, Anderson, and Mihalko are members of the AAOS Biomedical Engineering Committee.

Disclosure information: Dr. Urish—no conflicts. Dr. Anderson—Pioneer Surgical; Stryker; Aesculap; Expanding Orthopedics; SI Bone; Spartec; Titan Surgical; Clinical Orthopaedics and Related Research; Journal of Bone and Joint Surgery–American; Journal of Orthopaedics and Traumatology; Journal of Spinal Disorders; Neurosurgery; Spine; Spine Arthroplasty Journal; AAOS; ASTM; North American Spine Society; Spine Arthroplasty Society; Spine section of AANS/CNS. Dr. Mihalko—Aesculap/B.Braun; Saunders/Mosby-Elsevier; Journal of Arthroplasty;ASTM International.

References

1. Gilbert JL, Buckley CA, Jacobs JJ. In vivo corrosion of modular hip prosthesis components in mixed and similar metal combinations. The effect of crevice, stress, motion, and alloy coupling. J Biomed Mater Res 27, (1993) 1533–1544.
2. Jacobs JJ, Gilbert JL, Urban RM. Corrosion of metal orthopaedic implants. J Bone Joint Surg Am 80, (1998) 268–282.
3. Mao X, Tay GH, Godbolt DB, Crawford RW. Pseudotumor in a well-fixed metal-on-polyethylene uncemented hip arthroplasty. J Arthroplasty 27, (2012) 493 e13–17.
4. McKee GK, Charnley J, Hicks JH, Zarek JM. Symposium: the use of metal in bone surgery. Proc R Soc Med 50, (1957) 837–846.

AAOS Now
April 2013 Issue
http://www.aaos.org/news/aaosnow/apr13/research4.asp

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by Bethany Johansson

Our hips are an important part of the human body. A healthy hip not only improves mobility, but can also be crucial when it comes to high quality of life. Unfortunately, over time, many individuals develop arthritis in their hips—which may require artificial hip implantation. While many hip implants last for years, others can become faulty after a few decades’ worth of use. To avoid serious complications, individuals who have undergone hip replacement in the past should be aware of hip pain, decreased flexibility, hip swelling, increased fatigue, and other side effects that suggest your hip implants may be hurting you. This is especially true of specific models of metal-on metal hip implants including DePuy Orthopaedic’s ASR TM total hip system and Zimmer, Incorporated’s Durom Cup.

According to most experts, on-going hip pain is one of the most common symptoms associated with faulty implantation. While this pain may vary in intensity, it often presents as a dull ache—not a sharp stabbing discomfort. In most cases, individuals who are diagnosed with faulty hip implantation experience discomfort in the groin or lower back, in addition to that felt in the hip itself. Individuals who experience this symptom should seek medical attention as soon as possible to avoid further damage to the joint. 

Decreased Flexibility

Flexibility typically refers to the ability of the human body to move and work in the ways in which it was designed. Unfortunately, decreased flexibility is another common sign that a hip implant may have failed. Individuals who suffer from decreased flexibility years after a hip implantation may also begin to notice that the joint in question is stiff and difficult to move. While flexibility exercises and physical activity may be effective at managing some of the symptoms associated with faulty hip implantation, additional therapies—such as medication use or invasive procedures—may also be required. 

Hip Swelling

According to Drug Watch, hip swelling may also indicate potential implantation failure. Depending on the severity of the failure and on-going complications, the severity of the swelling may be quite variable. In most cases, the sooner that hip swelling is identified in patients who have undergone this procedure in the past, the better the final results of provided health care. Consultation with a nurse, physician, or other health care provider during the early stages of hip swelling may mean the difference between prescription medication use and invasive surgery—which in some cases, may be life threatening.

Increased Fatigue

On-going fatigue is a chronic health condition affecting many individuals living in the United States, and for that matter, the world. While fatigue is an everyday occurrence for some people, it may also be a sign of a more serious health problem, such as the failure of a hip implantation. Experts agree that a change in sleep habits is one of the best indicators of hip implantation disturbance or disruption. Those who have noticed a change in their ability to fall asleep or stay asleep over the past few weeks—and cannot identify a legitimate reason for the fluctuations—should seek medical assistance as soon as possible for rapid treatment and care.

About the author:

Bethany Johansson is an avid health writer and landscape photographer. To learn more about her, please visit her on Google+

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I am so very happy to have discovered your website!  My husband had a total hip replacement in Aug 2008 in Las Vegas, NV.

He was 46 years old at the time.

We felt like we had done our homework and picked a good surgeon and hospital. We both sell medical products so felt good about making informed choices.

Our surgeon implanted the Biomet M2a assuring us it was the best choice for a young athletic patient.  Surgery went well.  Intitial recovery was a bit slower due to my husband becoming very anemic due to a large loss of fluid due to vascularity.   However, by Jan 2009 he was doing pretty well and exercising again on a fairly regular basis.

Later into 2009, my husband began having unusual symptoms: extreme anxiety and fatigue, forgetfulness, ears ringing, hearing loss etc. Symptoms came on very gradually but by the beginning of 2010, I was becoming very concerned with his mental health.

I was downsized from my job and my husbands company offered to transfer him back to NM so we could be closer to his elderly parents who were soon to need some assistance.

We moved in May of 2010 and by then I really thought I was going to have to need his family’s support to care for him instead.  He was confusing people for other people he knew.  Other symptoms included falling asleep in airports waiting for his flights (work required flying to Phoenix every week), wandering around parking garages looking for his car for an hour and a half, driving into not great areas and getting mugged because he input the wrong address into the GPS-include in these odd behaviors not being able to feel your hands and feet, hypothyroidism, tachycardia and tinnitus.  His hip was hurting as well as making popping, grinding and squeaking sounds.  (His surgeon in Las Vegas said it was “snapping hip” syndrome  at 1 year followup visit-so it was beginning to fail as soon as 1 year later).

We went to see an orthopedic surgeon in NM in Dec 2010 because of the pain and noises his hip was making.  Although the xrays showed the implant was in place, the surgeon suggested my husband get his cobalt and chromium levels tested since he had a MoM device.  Because of an insurance glitch, we decided to check the levels in Jan 2011 but never got around to it – at least not right away.

In early Feb 2011, the ortho surgeon’s office called to see if he had had his metal levels checked yet and so we had the blood drawn on Feb 24, 2011.  2 weeks later, we got an alarmed call from the ortho saying we needed to come in right away.  My husbands cobalt level was >100ug/L and Chromium was 49.5ug/L.  However, the NM surgeon could not do a revision until the end of May, 2011.

At that point, my husband went on medical leave and we flew back to Las Vegas to see the original surgeon.  Although the surgeon was carful not to verbally talk about the effects of the high metal levels, he was alarmed enough to schedule surgery the following week in Las Vegas.

His original plan was to replace the ball mechanism but due to it being ‘cold fused’ onto the femur component, it had to be a complete revision which lasted around 6 hours.  We stayed in Las Vegas for about a week and after the hospital discharged him I took him to the hotel for a few days and then flew home-not an easy trip.

While recovering from the surgery, my husband had a cardiac workup due to tachycardia and also was discovered to have hypothyroidism (march 2011).  On May 13th, my husband suffered an anterior dislocation of his hip.  It was reduced at the ER.  Then, it dislocated anteriorly again May 24th and during the reduction, a portion of his trochanter broke.  The ER discharged him and he was left to stay in bed with a brace for a week until we could once again fly to Las Vegas for yet another surgery (No surgeon in NM would treat him at this point).  Revision #2 was performed on June 2, 2011 with a plate screwed into his femoral component to secure the trochanter. Another 6 hour surgery and severe anemia.

Cobalt had dropped to 15ug/L.

We stayed in Las Vegas another week at the hotel and then once again flew back to NM.

My husband returned to work Aug 29th, 2011.  His territory was changed and he was flying to Denver every week.  By Thanksgiving, he was really run down(can’t imagine the cause?) and was hospitalized with pneumonia and a bowel obstruction.  He was close to dying but amazingly pulled through.

All of this due to a MoM hip replacement.

Like many, we have a suit against Biomet to be tried in Indiana-I will be shocked if we ever see anything come of this.  What I can tell you though is that this has changed our lives forever.

Viki

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Earl,

Barry Meier’s recent article in the NYT about surgeons not speaking up about the metal-metal hip failures that they are witnessing is largely correct but the problem is also that those surgeons that do speak up, even if they shout, might not be heard because those listening are deaf or are pretending to be.

I began inquires to DePuy design surgeons, engineers, sales staff, and executives about my ASR and that of one of my patients in the spring of 2007. My cobalt levels were off the chart and my hip pain was reoccurring. “No worries Dr. Tower, nobody is reporting problems.” We now know that Drs Langton and Nargol had been lighting up DePuy’s switchboard at this time.

I continued to express my concerns to the same parties several times a year until my ASR was explanted in November of 2009. By that time I had experienced a partially disabling neurologic illness (mood changes, cognitive decline, tinnitus, high frequency deafness, and early blindness) and a cardiac illness (stiffening of the heart). Always the same answer, “Dr. Tower, cobalt poisoning has never been reported.”

Once my ASR was explanted my suspicions were confirmed, my neurologic and cardiac illness resolved in step with my declining cobalt levels. I wrote up my experience and that of my patient and submitted it to an Orthopedic journal and to DePuy by early 2010. A reviewer nixed the paper, he had published favorably on metal-metal hips. DePuy did not comment on the manuscript. A brief report was published in the spring of 2010 in the Alaska State Epi Bull, it was noticed by CDC Atlanta who wished to publish the report nationally. The FDA nixed the CDC, “our turf, back off, we are studying the issue.”

At the end of 2010 my paper was published in JBJS but I had to do an end run around the section editor who was a DePuy consultant. I attempted to present a the Annual Meeting of the American Academy of Orthopedic Surgeons in 2011, 2012, and 2013 my applications were rejected by a hip program committee, the majority of which were consultants for arthroprosthetic companies vested in metal-metal hip technology. In my stead design or consultant surgeons for companies with a strake in metal-metal hip were selected to address the poorly understood complications of chrome-cobalt metallosis.

I appealed to the Presidental Line of the AAOS starting at the end of 2010 to be given a chance to present the “Alaskan” experience with the local and systemic complications of chrome-cobalt metallosis in AAOS publications, “Webinars,” and meetings. The President and Vice President were DePuy consultants, another VP was a Zimmer consulted and had stock options in a company vested in metal-metal technology, only one member of the AAOS Presidental line was without obvious direct Conflict of Interest concerning metal-metal hips.

I did not fair better in attempting to influence the FDA. “Dr. Tower, you do not understand, when we believe their is a problem with a medical devices we sit down with experts forwarded by your professional organizations and industry to determine whether a problem exists, you have not been recognized as an expert by either, you have no standing with us.”

The underlying problem is surgeon-industry COI. The orthopedic literature, the committees that determine who presents “science” and opinion at meetings, the governance of the AAOS, and those that advice the FDA are a Cabal of orthopedic surgeons that work with arthroprosthetic companies vested in metal-metal hips. Their influence is so prevalent that it seems unlikely that internal reform of either the AAOS or the FDA is possible.

Your local orthopedic surgeon might not know about the frequency, nature, and severity of the metal-metal hip complications because the material that is published in the orthopedic literature and that presented at meetings, and to the FDA fails to recognize or underestimates these problems.

Your “Blog” is a critical resource to educate patients and physicians about the nature, frequency, and severity of the metal-metal hip complications. It is necessary to do an end run around organized American Orthopedics and the FDA.

Stephen Tower, MD

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“What a Mistake,” says DePuy Hip Recipient

February 14, 2013, 01:30:00PM. By Jane MundyShare on linkedin Share on facebook Share on twitter Share on email More Sharing Services

Morganton, NC: Chris was only 39 years old when he was implanted with a Depuy metal hip. He has spent the last seven years in pain, dulled by Oxycontin and Percocet.

“I had complications right after the surgery and I had a hard recovery,” says Chris. His doctor told him that the rounded top part of his femur had necrotized or died, and he needed to have a hip replacement. His recovery was spent mainly in a recliner, wearing boxers and a T-shirt.

“I couldn’t move,” Chris explains. “My mom had to take care of me; she even had to bathe me. That went on for about two months, then I moved to the sofa for 18 months – I couldn’t even make it to my bedroom in all that time.”

Fast forward to 2013 and Chris’ condition hasn’t improved much. “Most of the time I am ambulatory with a cane and sometimes in the night I wake up screaming in pain,” he says. “I have to keep my butt higher than my knees so my partner helps me to the chair in the living room (where I usually sleep) and then I take more pills for breakthrough pain.

“Then my surgeon determined that my hip was settling but I now have one leg considerably longer than the other. So I can’t stand for very long now that I have one leg longer than the other. I had to get a flu shot and wound up sitting on the floor because I couldn’t stand in line. We recently went to the movies, what a mistake that was. I didn’t take a cane or cushions and, as you know, the seats are very low in the theater. We made it to the end of Star Trek when I realized that I couldn’t walk out of there – my partner had to practically carry me out to the car.”

In 2010 Chris went back to his orthopedic surgeon and had more x-rays. “He told me that one of the hooks on the side of the hip came loose and slid down. They recommended revision surgery but I went through so much hell already I couldn’t do it.

“Now I am just waiting until I have to be put into a wheelchair. They said the second surgery will be worse because they have to chisel the bone off the rod that is running down the center of my hip replacement. Nobody explained why I was having so many problems.

“Then I heard about Depuy’s ASR hip recall on TV, and bingo, that has been my problem all along. I ran into so many people who had hip replacements at the same time as me and they were fine. My accountant was shocked to see my condition. He is much older than me and didn’t have one bit of trouble. My surgeon told me that these metal-on-metal hip implants have a 98 percent recovery rate so I guess I fell into that 2 percent. I was furious because I knew something was wrong all along and the doctors wouldn’t say anything. I think they knew that they screwed up.

“I used to ski, hike and swim. Tennis was my favorite sport and I miss it so much. I can’t do any of that anymore. All I can do now is watch videos on the computer or watch TV. As you can imagine, I gained weight (I just went on a diet) since I had my hip replaced. I can’t lose weight by exercising, and because I can’t exercise, my whole body aches. I guess I will get revision surgery at the last minute, if they can still do it. The doctor told my mother that my hip might not even be able to get fixed again, so that has made me even more hesitant.”

According to the National DePuy Orthopaedics Lawsuit Claim Center in the US, orthopedic surgeons increasingly believe the DePuy metal-on-metal implant had a design flaw that made it difficult to implant properly, specifically that the component has a narrow window for proper placement.

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This week, a bioengineer for Johnson & Johnson’s DePuy Orthopaedics unit testified in Los Angeles state court in the first of 10,000 DePuy ASR lawsuits to go to trial. According to Bloomberg News, James Anderson worked on redesigning the ASR for three years before the project was ended; even though he found ways to potentially lower the amount of metallic debris released by the metal-on-metal hip implant, no changes were ever implemented.

(PRWEB) February 08, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, recounts the latest DePuy ASR trial developments reported by Bloomberg News. Bloomberg News reported on February 7th that James Anderson, a bioengineer for Johnson & Johnson’s DePuy unit, testified in Los Angeles state court at the trial of Loren Kransky, whose DePuy ASR lawsuit is the first of 10,000 to go to trial (Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County). According to his videotaped testimony, Anderson worked on redesigning the ASR hip implant for three years before the project was ended. Anderson testified that he found ways to decrease wear on the cup, but no changes were ever made to the now-recalled metal-on-metal hip implant.

http://www.bloomberg.com/news/2013-02-07/j-j-engineer-studied-hip-redesign-for-3-years-jury-told.html

“Again, we have evidence that Johnson & Johnson was aware of problems with the ASR hip implant prior to the recall in 2010,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “Despite knowing that this hip replacement has a high rate of wear, J&J did not actually make the necessary changes to try and improve the ASR.” Parker Waichman continues to offer free legal consultations to hip replacement patients implanted with the DePuy ASR, along with other all-metal hip replacements. The firm advises hip replacement patients to speak with their surgeons if they experience symptoms such as:

•     Pain
•     Swelling
•     Difficulty walking, or a change in your ability to walk
•     Popping, creaking, or other sounds emanating from the area of the implant
•     Metallosis, high levels of metal ions
•     Early failure, revision surgery

According to Bloomberg News, this week jurors heard a videotaped testimony from Anderson stating that he was disappointed when the project to redesign the DePuy, known as “Project Alpha,” ended in 2008 without any changes to the all-metal hip implant. Anderson joined a team to study the “next generation ASR” in 2005. On April 7, 2008 he wrote to a superior, stating that “a small improvement to geometry could represent a large improvement for many patients.” In a separate document he wrote that by removing the groove on the ASR cup, wear on the cup “is approximately threefold less than the original design with the groove.”

Johnson & Johnson never implemented any changes to the ASR hip implant, which was recalled in 2010 due to a high failure rate. At the time of the recall, the company said that the implant failed in 12 percent of patients within five years. More recent data from an Australian national joint registry showed that the failure rate exceeded 40 percent.

This week, jurors also heard an expert witness testimony from a McGill University professor who stated that the ASR implant had a number of design defects causing it to fail more than other hip replacements. He said that cup shape, which is less than half a circle and has thin walls, attributed to the defective nature of the implant. 
http://www.bloomberg.com/news/2013-02-06/j-j-jury-told-hip-has-many-design-defects-causing-failure.html

The U.S. Food and Drug Administration (FDA) has issued new guidelines for patients implanted with metal-on-metal hip implants such as the DePuy ASR. In a Safety Communication issued January 17th, the agency advised physical examinations, diagnostic imaging and metal ion testing as needed. The FDA is also looking to tighten regulations on all-metal hip replacements that would require manufacturers to prove the devices are safe and effective before selling them. 
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm’s Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact: 
Parker Waichman LLP 
Gary Falkowitz, Managing Attorney 
(800) LAW-INFO 
(800) 529-4636 
http://www.yourlawyer.com

Read more: http://www.sfgate.com/business/prweb/article/DePuy-ASR-Trial-Update-J-J-Engineer-Suggested-4264231.php#ixzz2KRdsVdyA

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Implant Risk Was Assessed Inadequately, Court Is Told

By BARRY MEIER

Published: January 31, 2013

A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.

The engineering report, which was done in 2010, also found that Johnson & Johnson’s orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.

The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.

In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.

“They did their job, but they could have done it better,” Mr. Smith said.

Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.

Depending on the surgical technique and a patient’s build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint’s cup and ball components to strike each other, releasing metallic debris inside a patient.

DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.

Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial’s proceedings were monitored over the Courtroom View Network.

The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.

In the post-recall review in 2010, DePuy engineers examined the criteria and “controls,” or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.

Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device’s records demonstrated “that the product is more likely to experience contact between the head and rim” than competing implants.

In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.

Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device’s problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.

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Study reveals risk factors for hip replacement revision surgery

Published on 18 December 2012

A study has shed light on factors that increase the risk of needing revision surgery following an initial hip replacement procedure.

Results show that patients who were aged 75 or under at the time of their initial surgery were more likely to need revision surgery than those who were older.

Taller patients were also more likely to need revision surgery, as were those with a high body weight.

Other risk factors for revision surgery appear to be a history of prior orthopaedic surgery and use of a cemented femoral component.

Scientists at Brigham and Women’s Hospital and Harvard Medical School in the US looked at data on patients who had a hip replaced between July 1995 and June 1996, each of whom was matched with a control patient.

In total, they looked at 719 pairs of patients, as well as their hospital records in order to observe any potential risk factors.

Publishing their findings in the journal Arthritis Care & Research, the study authors claimed that their research is the first such US study to look for risk factors for hip replacement revision surgery.

They concluded that “younger, taller and heavier patients, and those receiving a cemented femoral component, had a greater likelihood of undergoing a revision total hip replacement over a 12-year follow-up period”.

“Effects of age and body size on revision risk should be addressed by clinicians with patients considering primary total hip replacement,” they added.

A spokeswoman for Arthritis Research UK commented that the number of hip revision operations was increasing and, when performed by specialist surgeons, could give reliably excellent results, despite a slightly higher risk of complications than in first-time hip replacement surgery.

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Hip arthroplasty devices, including metal-on-metal (MoM) hip systems, have been available and in use within the United States for over 50 years. They are frequently used to relieve pain and restore joint function in patients with chronic hip pain or disease which is not responsive to more conservative therapy. All told over 400,000 hip arthroplasty procedures are performed in the United States on an annual basis (Appendix A).

With widespread use of these MoM hip systems, more information has become available regarding clinical performance as well as adverse events.  Recent data from orthopaedic implant registries as well as peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with MoM hip systems including:

1.   Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (“ALVAL”);

2.   Early device failure and the need for revision surgery; and

3.   Systemic complications from metal ion exposure.

FDA believes that in keeping with its public health mission, it is appropriate to have an open and transparent dialogue among manufacturers, physicians, researchers, the public, and FDA to review currently available data regarding MoM hip systems in an effort to better characterize any potential and real safety risks and generate scientifically-based recommendations for the clinical and patient communities on how to best communicate and mitigate them.

This Advisory Panel meeting is not intended to: (1) reassess the original market entry data; (2) discuss the current or future classification of MoM hip systems; or (3) discuss mandated postmarket studies (i.e., “Section 522” or “post-approval” studies) currently underway for MoM hip systems.

DOWNLOAD the full document as a PDF – MOM hip implant systems

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