Cobalt Chromium Toxicity

Hip Recall News

Can Cobalt and Chromium Ions from My Hip Replacement Cause Organ Damage?

hipMany hip implants contain metals, including chromium and cobalt, that are toxic. Metal ions released from the friction of metal-on-metal implants can cause pain, pseudotumors, and other problems surrounding the joint. But did you know that these ions can travel systemically throughout the body and find their way into organ tissues?

A team of researchers investigating defective metal-on-metal hip implants used X-ray absorption spectroscopy (XAS) to show that these metal ions can find their way into organ tissues, such as the liver, spleen and heart. Depending on whether the patient suffers from other chronic health conditions, it is possible for some of these ions to oxidize within the organs and form more dangerous substances, leading to debilitating and potentially deadly conditions, including cancers.

Systemic release and absorption of metal ions from defective hip implants puts patients at serious risk. Further toxicological studies are necessary to determine which patients are at high risk of tissue damage, cancer, and other systemic issues.

What Do I Do If I Believe My Hip Implant Is Harming Me?

Call Kershaw, Cook & Talley at (888) 817-2527 to schedule a free consultation. We represent hundreds of metal-on-metal hip replacement patients who have relied on us for decades to provide our knowledge and expertise in fighting and winning cases for victims of defective medical devices. You should not have to suffer due to a recalled or defective hip implant, and we are prepared to help you and your family.

DePuy Pinnacle 2016 Trial Update 5

Hi, Stuart Talley here, doing another update on the DePuy Pinnacle trial currently pending in Dallas, Texas. We are a couple weeks into the trial now. We have Dr. Pam Plouhar, head of clinical research at DePuy, on the stand today talking about a study and clinical trials that were done on the Pinnacle hip after it was released to the market. She was subjected to intense cross-examination by the plaintiffs’ attorney about the study and clinical trials.  In particular, there was an advertisement released by DePuy that was submitted to doctors, published by medical journals, and published in media directly designed for patients. One of the key phrases in the advertisements for Pinnacle hips reads as follows:

“There were nearly a million [Pinnacle hips] implanted over 10 years. 5 years after surgery, 99.9% are still in place.”

The implications from the ad is that there were millions of hips put in over 10 years, and if you look at all the hips that were in for 5 years, 99.9% of them were still in place. Today, we learned this is not entirely accurate. In fact, it’s blatantly false. The study they used to support that statement was called the PIN study. Dr. Plouhar was responsible for that study. The PIN study didn’t look at the million hips that were implanted; it looked at about a thousand hips that were implanted over a short period of time. When DePuy states the hips are still in place, well, the study doesn’t look at how many hips were still in place. These Pinnacle hips have multiple parts: stem, ball, cup, and inside the cup is a liner. The PIN study only looked at the number of hips that were replaced with respect to the cup. So, if the cup had been removed, that was considered a failure under the study. When they supposedly looked at all these hips, a thousand that were implanted, there was only one hip where the cup had been removed. However, it turns out, there were many hips requiring revision but they did not involve removing the cup. Many times the way a Pinnacle hip is potentially revised if the patient has metallosis is replacing the liner within the cup. So, there were a lot of revision surgeries that took place but they did not involve removing the cup. This study that said there was a 99.9% statistic was only looking at removal of the cup.

As the trial progressed, we learned there were many problems with that study. It was false when the study announced there was only one cup removed. There were lots of cups that were removed, much more than one. Another issue with the study, is DePuy told everyone in the medical community that this was a “prospective study”. A prospective study follows a group of similar individuals who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome, over a period of time. In this case, it means you bring potential hip patients into a doctor’s office, you enroll them into the study, they have an initial surgery and you follow their progress.  A prospective study is important because if it is not a prospective study then there is a risk the doctor could cherry pick patients; meaning the doctor could say, “I think this hip works great on this patient. I am gonna put them in the study.” But then if someone comes in who is possibly overweight or has other medical problems, the doctor could say, “I won’t put that person in the study”. So, by informing the public it was a prospective study, DePuy was announcing that it was a reputable study; all patients requiring a hip implant would receive one, despite their different factors, and they would be enrolled in the study. It turns out, many of the patients who were implanted with the hip were not admitted into the study. Rather, DePuy had admitted people into the study who were already implanted months before the study began. This was a serious case of cherry picking.

The other submission made in court was the way this study was drafted. This study was presented at the American Association of Orthopaedic Surgeons (AAOS). However, even though DePuy was the author of this study, there name was not on it. There are emails at DePuy, once the study was completed and the results of the study were drafted, between executives wondering who would be the author of the study.  There are email chains back and forth between DePuy executives where they are wondering who would be the best author for this study that they had already drafted. Once they decided the author, minor edits were made and then it was submitted. This is a classic problem that occurs in the medical device community and pharmaceutical industry where you have companies using scientific literature to sell their products. But the companies do not inform the doctors or the patients that the cited and published studies are actually funded by the companies and the final results are drafted by the company. The plaintiffs made a good showing that this was occurring with DePuy.

From the very beginning, this PIN study was a marketing study. DePuy was not researching and analyzing how good their product was and how they can improve or change it. They did not have some scientific inquiry on how to better their product but instead this study was the brain child of the marketing department. They wanted to do the study in order to gain market share. There are emails from the DePuy marketing department showing them asking how much it would cost to do the study, approximately $400,000, and then there was an analysis of how much the study would increase sales. There is a memo demonstrating the study would cost a certain amount but then generate millions of dollars in sales.

This is currently the progress of the case. We have a situation where the manufacturing of this hip was dominated by the marketers at DePuy. This is not unusual considering the CEO of DePuy was a marketer; he worked his way from marketing to CEO. The culture of this company is one where sales are the driving force.

DePuy Pinnacle 2016 Trial Update 4

Hi, I am Stuart Talley. I am doing another video about the DePuy Pinnacle hip trial that is currently pending in Dallas, Texas. Today, the plaintiffs put on the stand more witnesses for the case. We heard from a Professor Drumwright who specializes in Marketing and Business Ethics. She was called by the plaintiff to give testimony about the way DePuy marketed the Pinnacle hip. She gave testimony regarding how marketing and advertising influences the decision of patients and doctors.

DePuy spent millions of dollars on marketing. Their position in the case is that the marketing is irrelevant, and that it doesn’t matter what the ads say because they are false and fraudulent. They are taking the stance that doctors don’t decide what hip to implant into a patient based off an advertisement. So, Professor Drumwright was called to talk about how marketing does sway doctors and makes a difference in their decisions. She spoke about published literature on this issue. She also talked about DePuy’s overall marketing scheme.

The scheme involved paying a doctor to have a meeting with other doctors in the area, and the paid doctor would then tell the other doctors to promote and talk about the metal-on-metal hips. The problem is many of the doctors promoting the hips were receiving royalty payments upwards of millions of dollars. This was never disclosed to any of the other doctors that showed up to those meetings. There were other issues as well in regards to DePuy having medical journal articles ghost written by doctors (they write the article but remain anonymous).

Most of the day was testimony by Professor Drumwright and there was cross-examination of her. DePuy made the point that the doctors who performed the operations on the five plaintiffs were never present at the aforementioned meetings where the paid doctors were presenting; many said they never saw the advertisements for the hips. Nevertheless, Professor Drumwright pressed the point that when you are talking about devices in the medical community there is a consensus that is reached. The consensus is that when one surgeon in a surgical group starts using a certain product, word spreads to other surgeons that it’s a good product and they start using it. So, it’s the point isn’t whether or not a doctor saw an ad but if a doctor saw another surgeon who saw the ad start using the device, then that doctor might start using it too.

After Professor Drumwright, the plaintiffs called Pamela Plouhar, head of clinical research at DePuy during the Pinnacle development. Dr. Plouhar was in charge of clinical studies. A clinical study is conducted on people starting from initial implantation with a device and following their progress. DePuy used a clinical study called the PIN study. Basically, the PIN study was conducted on 1,100 patients who received metal-on-metal Pinnacles to examine the survival rate of the hips. The data of this study that DePuy paid for was used in marketing. The main statistic from the clinical trial that they reported often in their advertising was 99.9% of the Pinnacles implanted at the beginning of the study were still implanted after 5 years. The plaintiffs’ attorney went to great lengths to analyze and discuss the irregularities with that study.  According to Dr. Plouhar, out of the 1,100 patients only one was revised in order to calculate to obtain the 99.9% statistic. The plaintiffs’ attorney analyzed all the documents and they found there was more than one revision occurring with those hips. At one point in the testimony, there were 8 revisions. DePuy was still using the 99.9% statistic even though they knew there were 8 revisions in this study. The point was clearly made that the 99.9% figure was false. Dr. Plouhar refused to admit it was false; she would say it was inaccurate but would not admit it was fraudulent.

There were many other irregularities with the study. One document was a case report for one of the patients in the study. The study was conducted starting with the implantation of the Pinnacle hip and subsequently the patient would follow up with the doctor at regular intervals after their surgery. The doctor would fill out a form which said the patient was seen on a particular day, the patient was doing well and calculate a “Harris Hip Score”, which essentially tells you how the hip is doing. The doctors would then submit these forms to DePuy. These forms were how DePuy kept track of the hips after they were initially implanted. One of the forms they analyzed was from a patient where the doctor implanted the hip in 2006, and there were several reports revealing the doctor had examined the patient in 2007, 2008 and 2009, and that the hip was doing great. Well, the plaintiffs’ attorney disclosed a document showing that the patient showed up at the surgeon’s office in 2010 and reported that their hip had actually been revised back in 2007, before the doctor said he had examined the patient.

The testimony and documents demonstrated that his doctor falsified data. He had falsely reported he had seen the patient and that the patient was doing well. The patient was not doing well and had the hip revised only a year after it was initially implanted.

DePuy Pinnacle 2016 Trial Update 3

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the recent DePuy Pinnacle metal-on-metal hip trial. Currently, there are five cases being tried in Dallas, Texas. It’s being tried in a joint trial on behalf of five people. We are providing updates on what’s happening in the trial and we are following it very closely.

Andrew Ekdahl, former CEO of DePuy, was on the stand again. He was CEO when the Pinnacle hip was developed. During cross-examination of Mr. Ekdahl, there was a lot of startling admissions that were made by him throughout the trial and a lot of interesting information was revealed. First, the plaintiffs’ attorney was able to get Mr. Ekdahl to admit that when the Pinnacle metal-on-metal hip was released to the public, DePuy had no idea the health impact of metal ions released from the head. There were a series of documents back in 2000 and 2001 where engineers and doctors working for DePuy were having some concerns about metal ions released from the hip. Mr. Ekdahl admitted they sold the product for many years without knowing what the true health impacts were.

Another line of questioning went into the safety of the Pinnacle. One of the defenses DePuy has brought up is that the reason the failure rate and the revision rate for the Pinnacle is so high is because of lawyer advertising. They’ve painted this picture that there’s ads on television and that people with perfectly good hips ran to their surgeons and asked to have their hips revised because they saw it on television. The plaintiffs’ attorney did a good job defusing that entire line of defense. The reason the hips were being revised and the reason DePuy stopped selling so many was due to so many problems with the hips.

There was a series of articles and medical literature during 2008 through 2010 calling into question metal-on-metal hips. There was also a series of newspaper articles describing problems with these hips and the fact that doctors had to revise them. And so the idea that the Pinnacle was taken off the market because of lawyer advertising and because of people getting unnecessary revision surgeries was invalidated. There was a slew of evidence that the reason doctors stopped using the metal-on-metal hips was because they were having problems with them.

A different line of questions that took place was shocking. It involved DePuy’s conduct with a ball called the A-sphere. The story told at trial was that in 2008 lots of doctors were calling into question metal-on-metal hips. So, 2008 through 2010 articles are released indicating metal-on-metal may not be as safe as the manufacturers would have us believe. Internally, DePuy was concerned about these articles. DePuy came up with a plan to create a new ball and call it the A-sphere. They would then tell the medical community that this new ball was much better than the old ball because it greatly reduced metal wear debris. So, they came out with the A-sphere and there was a series of emails between marketing and engineering where they are discussing the A-sphere ball. In those emails, it becomes clear that the A-sphere was no different than the other ball and it was purely a marketing trick. There is an email from an engineer saying why don’t we take the old balls and change the name because it’s the same thing. That line of questioning was shocking and you were able to see behind the scenes of how marketing and profits drove a lot of the decisions of this company.

During opening statements, the defense attorney made a lot of comments about how DePuy and Johnson and Johnson are great companies. The judge ruled that opened the door for the plaintiffs introducing evidence they aren’t good companies. One of the key pieces of evidence that was introduced with Mr. Ekdahl is called a deferred prosecution agreement. Back in 2006 and 2007, DePuy was in trouble because they were caught paying bribes to surgeons to use their hips. The FBI investigated and eventually DePuy entered into the deferred prosecution agreement. So, they agreed to change their practices and not bribe surgeons anymore. They acknowledged that they were doing it and they took responsibility for it. As a result, the attorney general agreed not to prosecute them criminally. Mr.Ekdahl was asked about the deferred prosecution agreement but he refused to acknowledge any of the facts in there. When he was asked whether DePuy paid bribes to doctors and surgeons he said that they didn’t. And when he was asked why he was not taking responsibility, he didn’t have an answer.

There was a lot of advertising for the Pinnacle about a 99.9% success rate. They were telling doctors and advertising that there was one study where they put in 3,000 of these hips and none of them were revised when this was false. The defense argued during openings statements that these advertisements really don’t matter. They argued doctors do not rely advertising; when they make medical decisions they rely only on the science. During the cross-examination of Mr. Ekdahl, the plaintiffs’ attorney was able to show that DePuy spent millions of dollars on advertising. They had a sales force that would go out and advertise and try to get doctors to use their products. They also spent millions of dollars during the 2008 Olympics on direct-to-consumer advertising; television ads, newspaper ads and magazine ads using Coach K as their spokesperson. Coach K never actually had a DePuy Pinnacle hip but they used him as a spokesperson anyway. So, if advertising doesn’t matter, why was doing spending so much time and money doing it? Mr. Ekdahl was unable to answer these questions.

The final part of the day concerned medical research that had been done. There was a point in time about concern with metal-on-metal and the impact of metal ions on patients. There was a series of emails between the people at DePuy and a surgeon in the medical community who agreed on performing a clinical study. He would do a study with individuals to show how the Pinnacle hip compared to other hips. The interesting part of the emails was how Mr. Ekhdal and the researcher discussed how they would structure the funding of the study so if the study came out negatively, DePuy could claim they had nothing to do with the study; if it is a DePuy funded study, and it has negative results, DePuy has to live with that. But if it’s a study without an association to DePuy, and it is negative, they can criticize it.

These emails and testimony revealed this company is guided by sales and profits more than the safety of their devices and the benefit and welfare of patients.

DePuy Pinnacle 2016 Trial Update 2

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the ongoing DePuy Pinnacle metal-on-metal hip trial that is currently taking place in Dallas, Texas. This cases involves five separate plaintiffs who allege they were injured as a result of metal debris that was being released from these metal-on-metal hips.

So, the plaintiffs called Andrew Ekdahl, DePuy’s former CEO, to the stand. Mr. Ekdahl has a long history of being in sales and marketing. He eventually worked his way to becoming CEO of this company. There was a big emphasis on the cross-examination of Mr. Ekdahl about his marketing background, and how someone with his background was running the company as opposed to someone with an orthopedic or scientific background.

One of the things that took up a lot of the day was cross-examination concerning memos from 1995. The story that’s being told through this trial is that in 1995 DePuy became aware that other manufacturers of hips were coming out with other bearing surfaces. So, at this point in time, most hips were made out of metal and plastic; plastic liners with the metal ball. There was a push in the industry to come out with metal-on-metal hips.

In 1995, DePuy got its lead scientists together to look at these other bearing surfaces. There is a detailed memo that was prepared by DePuy’s head of science where he describes the different bearing surfaces for the hips. He concludes that metal-on-metal has a history of not being a very good bearing surface. He talks about how in the sixties and seventies manufacturers came out with metal-on-metal hips, and there were lots of problems with metal wear debris.

In this memo, he talks about how the failure rate of these hips was much higher than with metal-on-plastic, how the metal-on-metal hips were leeching cobalt and chromium, and how toxic and poisonous those metals can be compared to hips with plastic.  Hips with plastic debris typically do not cause a lot of problems compared to the metal debris. In the memo, the head scientist at DePuy also says from the standpoint of innovation it makes more sense to come out with a better plastic, and modify the metal-plastic design than it does to go with the metal-on-metal design that has been shown to fail in the past. For some reason, the advice of DePuy’s head of science did not carry the day. DePuy eventually went into the metal-on-metal market with the DePuy Pinnacle, and then eventually the DePuy ASR Hip, which is recalled.

Interestingly, in the cross-examination there was also discussion about a meeting that took place with several doctors hired to come in and talk about these different bearing surfaces. There are minutes of this meeting which occurred back in 1995. The plaintiffs’ attorneys discuss how in 1995 the doctors who were consulting with DePuy indicated that a metal-on-metal design could potentially lead to litigation. So, there was this knowledge back in 1995 that metal-on-metal hips have failed in the past, that their failure rate was bad, that the danger from a metal-on-metal hip in the debris was much different, and more dangerous for the patients than the metal-on-plastic design. For some reason, DePuy chose to ignore all this advice in 1995 and went ahead with the metal-on-metal hip design. Apparently, this decision was based on market share.

There was also discussion at the trial with Mr. Ekdahl about the marketing and the way DePuy marketed its hips. DePuy spent millions of dollars on taking surgeons to dinner, go to conferences to talk about the benefits of metal-on-metal hips. The plaintiffs’ attorney went through some of the financial records in the budgets and it turns out that DePuy was actually spending more money on marketing and advertising than it was on research and development during this time period.  There was a big push to get market share.

The other issue that was mentioned during trial was that the doctors, the ones who were flying all over the country getting paid millions of dollars to talk about how great the metal-on-metal hips were, stopped using those hips almost within a year or two after they started. There were some doctors who only used it for two years. They saw the problems with the hips and they stopped using it. Despite, DePuy continued selling the Pinnacle hips to the public.

At the end, there was also lots of discussion about the way the DePuy Pinnacle was approved by the Food and Drug Administration (FDA). The defendants like to make a big deal of the fact the hips were approved by the FDA, so it must be a good product. During trial, it was stated that the hip was approved through a loophole in the FDA process. It was approved via the 510K process, a process where you can go to the FDA with a product, a product substantially similar to one approved previously but has a minor modification. Essentially, that’s how the hip was approved. DePuy submitted something similar to a hip that was already approved and on the market, and the FDA rubber stamped it. So, there was no testing, no clinical trials and nothing submitted to the FDA to prove that the device was safe and effective. Instead, all DePuy had to prove was that the Pinnacle was substantially similar to something else that was already on the market. The problem is that the device that was substantially similar to the Pinnacle was eventually pulled from the market because it was defective and had problems with metal wear debris. That respective device was also pulled from the market because it was shown to be substantially similar to these hips back in the sixties and seventies that were also pulled from the market.

The plaintiffs’ attorney did a great job demonstrating the “chain of devices” that led to the Pinnacle hip. The demonstration showed all of these devices had failed in the sixties and seventies, they failed in the early two thousands and they failed at the end of 2010. This completed the testimony for the day and it was definitely a good day for the plaintiffs. The defense has yet to go but there are some really damaging documents that were presented. The 1995 memos were very good for the plaintiffs and they support the fact that DePuy really knew there were problems with these metal-on-metal hip designs before they released the device on the market.

DePuy Pinnacle 2016 Trial Update 1

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the recent Pinnacle metal-on-metal hip litigation. As many of you may know, a trial recently started in the DePuy Pinnacle metal-on-metal hip cases. The trial is pending in Dallas, Texas and it is on behalf of five individual plaintiffs.

The trial started about a week and a half ago, and there has been opening arguments. So far, we have heard from the attorneys in the courtroom that the case is going very well. This hip case is unique because the judge has allowed five individual plaintiffs to go to trial simultaneously. All previous hip cases were usually one plaintiff and one defendant, and were tried in various jurisdictions involving different types of hips. In this case, we have five people who all underwent revision surgeries because of problems with metallosis and their DePuy Pinnacle hips.

During opening statements, the plaintiffs made a very good argument that DePuy knew there were problems with these hips, they did not adequately test the hips and they put them on the market any way. Additionally, the plaintiffs argued DePuy was putting profits over the wellbeing of people who are receiving these hips.

The defense, as you might expect, took the position that all five people and their problems had nothing to do with the DePuy Pinnacle hip. Specifically, they are claiming that some people had an allergic reaction, some people had infections, and that there is a reason for every person as to why their hips failed. According to DePuy’s attorneys, the hips failing has nothing to do with the defect in their hip. They also went to great lengths to explain the evolution of technology and medical devices, and how there was metal-on-plastic and how there were problems with that, and so they tried metal-on-metal and realized that wasn’t working very well, and now we are going back to metal-on-plastic. So, there is this argument that this is the natural evolution of technology and medical devices. They state sometimes they fail, sometimes people get hurt and that’s just the cost of doing business, so to speak.

I don’t know if that type of argument is going to fly with this jury. I think if technology is developed, a company has an obligation to test it before they put it in people. And if the theory is that this is our way of developing a product, sometimes good things happen, sometimes bad things happen, well then you have to pay for the bad things. At least, that would be my position.

So, that’s where the case is. There are lots of experts who have been testifying over the last couple of weeks. A lot of the treating doctors have been testifying as well. I think today one of the plaintiffs will testify and explain her experience with her hip.  I believe the trial is going well and I think the situation where we have five individual plaintiffs is going to make it very difficult for the defendant. It’s really easy when you have person saying, “Yeah, maybe our hip caused people problems but not this person.” Essentially, they have to say that five times in front of the same jury. That argument will be tough for the defense.

Stay tuned because we will provide additional updates.

Stryker Rejuvenate Status Update: October 2015

My name is Stuart Talley and I am the partner at Kershaw, Cook & Talley responsible for the Stryker Rejuvenate recall litigation. The reason I am doing this video today is to give an update on the status of the litigation. We had a status conference with the court yesterday and we wanted to provide an update on where we are with these cases.

As many of you may know, the Stryker Rejuvenate litigation originally involved about eight thousand cases that were filed on behalf of people who had Stryker Rejuvenate hips. Most of those cases were consolidated in Minneapolis, Minnesota before Judge Donovan Frank. After year and a half litigation, there was a global settlement that was announced.  It was actually a global settlement program. Any individual who had a revision surgery as of November 2014 had the option of participating in the settlement program.

The hearing yesterday discussed the current situation regarding where certain cases stand, how many have been settled, how many remain. We learned there are many cases still pending in the court that have not been resolved. Those cases fall under different categories:

  • The first category includes people who have not had revision surgery. Stryker has offered nothing to those individuals and is not agreeing to settle their cases.
  • The second kind of case involves people who had revision surgery but after the settlement was announced in November 2014. So, if you had revision surgery after November 2014 you were not included in the settlement program.
  • The third kind of case that is sitting out there is for people who opted out of the settlement program. They decided they didn’t like the terms of the settlement and decided not to take it.
  • The last category of cases, 175 remaining, those will be tried to a jury. There is a lot of work right not to get those cases ready for trial. There’s a lot of discovery that’s being conducted with respect to Stryker and retrieving documents from Stryker. There are many depositions lined up for November of this year of various Stryker executives. There’s a lot of work and effort going into getting those cases ready for trial.

With respect to the unrevised cases, people who haven’t had revision surgery, there is a process that will be set in place. Essentially, Stryker has agreed to allow these people to dismiss their case. In the future, if they ever need revision surgery, they can refile the cases as if it was never dismissed in the first place. This process is called a “tolling agreement”. Stryker agreed to “toll”, or suspend, the statute of limitations. For example, you dismiss your case and are allowed to refile if you ever have revision surgery. If you do, it’s as if your case was never dismissed in the first place.

These cases are ongoing. There’s a lot that’s happening. Many cases have settled. If you have a Stryker Rejuvenate hip, and have not filed a case, we recommend you file one immediately. The statute of limitations could be running on your case. And unless you actually have a case on file, you are not protected even if your hip has not been revised. This tolling agreement only applies to individuals who have cases on file.

If you have a Stryker Rejuvenate hip, contact us for a free case consultation. You can call us toll-free at (888) 817-2527, or fill out and submit the confidential submission form found on this page.

Zimmer Persona Knee Recall

Zimmer Inc. released the Persona Knee implant for Total Knee Arthroplasty (TKA) in March 2012. They marketed the product stating, “Zimmer is redefining knee arthroplasty and ushering in a new era of personalization with the introduction of the Persona Knee.”

On March 12, 2015, Zimmer Inc. recalled the Persona Knee after less than three years on the market. The recall includes approximately 12,000 implants sold throughout the United States. The recall was initiated because the knees are prone to loosening, resulting in severe pain for the patient and a subsequent need for revision surgery. 

Zimmer Recalls Persona Knee Implant

Zimmer Inc. issued a voluntary Class 2 recall of the Persona Trabecular Metal Tibial Plate. Recall notices were sent to affected distributors, hospitals, and surgeons in February.

According to the Food and Drug Administration (FDA), the manufacturer received “An increase in complaints of loosening and radiolucent lines.”  Radiolucent lines are defined as radiolucent intervals (measured in millimetres) between the cement and the bone. They are transparent to X-Rays. Radiolucent lines are symptomatic of a poorly-fixated knee implant, malalignment, and premature or aseptic loosening. Progressive radiolucent lines are commonly associated with early failure of the acetabular component of the knee implant. Component loosening and polyethylene wear may be attributed to the cementing technique and/or implant design.

The Australian Government released a hazard alert stating, “Out of the 0.61% complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, and 28% identified asymptomatic radiolucencies.”

Your Options & Filing a Zimmer Persona Knee Lawsuit

Zimmer advertised on their website, “The Persona System makes the most clinically successful knee replacement more personalized than ever by focusing on the unique needs of the patient, surgeon and institution.”  Unfortunately, individuals implanted with this defective device experience serious problems and may require revision surgery.

We recommend following up with your orthopedic surgeon regarding this matter. Consider requesting that your orthopedic surgeon order an X-Ray  or other radiological study in order to evaluate the current status of your Zimmer Persona knee. We believe it is in your best interest to have your knee evaluated due to the fact the implant can lead to loosening failure mode and contribute to the need for revision of the total knee arthroplasty.

Contact our attorneys today if you experienced the following issues:

  • Knee pain
  • Malalignment
  • Loosening of the knee replacement
  • Poor component fixation
  • Knee replacement failure
  • Decreased mobility
  • Pain with mobility
  • Revision surgery

We help individuals injured secondary to the Zimmer Persona and accept product liability cases nationwide. If you or a loved one was injured from a defective knee replacement,  call our lawyers immediately for a free case consultation at 888-817-2527, or fill out our confidential online form.

Smith & Nephew R3 Recall

The Smith & Nephew Reflection 3 (R3) Acetabular Hip was approved via the Food and Drug Administration (FDA) 510k process in 2007. Smith & Nephew Orthopaedics issued a recall for metal liners of the R3 acetabular system on June 1, 2012. The use of Smith & Nephew R3 in total hip replacements is associated with a higher than expected number of revision surgeries, prompting a market withdrawal of the devices.

The metal-on-metal liner is linked to various health issues including but not limited to:

  • infection
  • dislocation
  • metal sensitivity
  • loosening/lysis
  • fracture
  • difficulty walking and pain

Smith & Nephew recommends physicians maintain their typical follow-up protocol for patients who have undergone total hip replacement or resurfacing surgery and implanted with the Smith & Nephew R3. However, this advice can have adverse long-term consequences, both physically and financially.  You should immediately have your blood tested for cobalt and chromium whether or not you have pain, and/or swelling or other unexplained symptoms. Patients with cobalt and chromium levels above 0.3 micrograms per liter (mg/l) or parts per billion (ppb) require monitoring since these levels are abnormal.

You may be entitled to compensatory damages including:

  • lost wages
  • medical expenses
  • cost of disability
  • property loss or repair
  • pain and suffering
  • loss of consortium (if applicable)

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