Serving defective knee, hip and other joint replacement clients Nationwide.
Keefe Bartels is a personal injury and defective products law firm with years of experience in litigating medical implant cases for clients throughout the United States. Read more...
Zimmer Durom Hip Cup
More information and history.
The problems with the Durom Cup first came to light in 2007 when prominent orthopedic surgeon Dr. Lawrence Dorr, the Director Read more...
DePuy Hip Implant Recall
Updated Information
Despite being promoted as a breakthrough in hip replacements, the faulty DePuy A.S.R. (which stand for Articular Surface Replacement) is now being called "[o]ne of the most troubled orthopedic implants of the past decade.' Read More...
Defective Artelon CMC Spacer Attorneys
Our defective medical implant device attorneys are investigating potential lawsuits and legal claims related to the Artelon CMC Spacer wrist / thumb joint implant. Read more...
Metal On Metal Implants
Becoming a Mounting Problem
Over the last year, several major medical centers have begun treating a number of patients with medical problems directly related... Read more...
Our defective medical implant device attorneys are investigating potential lawsuits and legal claims related to the Artelon CMC Spacer wrist / thumb joint implant. Read more...
The U.S. Food and Drug Administration has launched a new website dedicated to concerns about metal-on-metal (MoM) hip replacement systems.
According to the FDA, patients should know that all artificial hip replacement systems have risks related to implant or material wear. However, metal-on-metal hip replacement systems have unique risks.
The FDA explains that “[b]ecause the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant.” Metal ions and particles from metal-on-metal implants may even get into the bloodstream. Read the rest of this entry »
For quite a while now, the commentators here at DefectiveJoints.com have been following the continuing problems of Johnson & Johnson’s Depuy Orthopaedics division, which makes medical device implants.
Last August, Johnson & Johnson issued a recall of its Depuy ASR hip implant due to continuing reports of the faulty nature of the defective replacement. Since then, the copany has faced a growing number of problems.
There has been a marked decline in the value of J&J stock. The president of Depuy Orthopaedics, David Floyd, has announced his resignation. And patients across the country have filed over 600 lawsuits based on injuries caused by the faulty Depuy hip implants.
But the story of those patients who have been injured by these defectively manufactured hip replacements has gone largely untold. This is why I was so happy to come across a recent news report out of Minnesota highlighting the patients’ side of this story. Read the rest of this entry »
According to recent data in the United Kingdom, the Depuy ASR hip implant is failing at a rate of 49%. The rate is four times higher than Johnson & Johnson’s orthopaedic division had indicated last year when it recalled the faulty hip implant.
“The British Orthopaedic Association and the British Hip Society said in a statement this week that data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.”Read the rest of this entry »
In August of last year, Depuy Orthopaedics was forced to recall its ASR hip implant. The faulty implant was on the American market for fewer than 5 years, but long enough to cause serious harm to the patients who underwent hip surgery with the defective ASR hip replacement.
According to a recent Bloomberg news report, David Floyd has officially stepped down as world president of DePuy Orthopaedics. Depuy is the division of Johnson & Johnson that produces artificial hip and knee replacements.
Floyd’s resignation comes amid continuing controversy about Depuy’s recall of its ASR hip implants. The New York Times recently reported that the ASR hip implants have been “failing worldwide at unusually high rates after just a few years.” Depuy’s faulty hip replacements have caused many patients to undergo painful revision surgery.
Since it was introduced in 2003, Zimmer has sold more than 150,000 NexGen CR-Flex artificial knees. However, the Zimmer NexGen CR-Flex knee replacement has been failing at an unusually high rate.
Patients complain that the implant parts loosen and shift. Even after a revision surgery, some patients experience nerve damage, tissue scarring, and reduced flexibility and mobility. Patients often find themselves still on pain medication months and years after the revision.
Knee implants are supposed to last 15 years. However, many patients with Zimmer NexGen CR-Flex replacements have had to undergo painful revision surgery within 3 years of the initial implant.
This past December 2010, the New York Times reported that Johnson & Johnson’s DePuy A.S.R. hip implants have been “failing worldwide at unusually high rates after just a few years.”Despite being promoted as a breakthrough in hip replacements, the faulty DePuy A.S.R. (which stands for Articular Surface Replacement) is now being called “one of the most troubled orthopedic implants of the past decade.”
Although evidence of the defective A.S.R. hip implant had been mounting for years, DePuy Orthopaedics, a division of Johnson & Johnson and the world’s leading manufacturer of hip implants, has continued to claim that there were no problems with the troubled A.S.R. Read the rest of this entry »
Data on the success or failures of hip implants is difficult to come by in this country, as there is no national joint registry that tracks these devices. Australia, however, does maintain such a registry, which collects data from every knee and hip implanted on that continent. This data is invaluable to patients and healthcare providers, as well as medical device manufacturers. Quite simply, this information reveals what implants are working and which are problematic.
The annual report of the Australian Joint Registry shows that the Profemur Z hip implant, manufactured by Wright Medical Technologies (Arlington, TN), amazingly shows an 11.2% failure rate at the three year interval (see page 104). This implant has a modular stem, meaning it is not one piece, but two (see photo). Theoretically, this allows the surgeon more options for modifying the implant geometry and should yield better results, however, the fact of the matter is that these Profemur Z implants are fracturing and failing at an alarming rate.
All this begs the question: where is the FDA? A review of the FDA’s adverse event reporting database shows 10 failures of these hips in the past 5 months, and it should be noted that it is generally understood that this database reflects a gross under-reporting of adverse events, meaning the actual number of failures is likely higher. Clearly the Profemur Z Hip stem is problematic and the issue needs to be addressed by Wright Medical Technologies.
If you or a loved one has suffered from a fractured Profemur Z Hip Implant, please contact us immediately to speak to an attorney.
In March of 2010, Depuy finally halted sales of its ASR metal on metal hip implant. While Depuy did not announce a formal recall of the device, and maintains that it is not defective, it is curious that they pulled the device from the market in December of 2009 in Australia, where the National Device Registry there showed alarmingly high failure rates of this device, yet continued to sell it in the United States, which also happens to be Depuy’s largest market. Depuy continued to sell this device to unsuspecting patients throughout the country despite the fact that the FDA has received approximately 300 complaints regarding the Depuy ASR cup since 2008.
The alleged problems with this implant are numerous and very serious. Some experts feel that the design of the ASR XL cup is too shallow, resulting in hip implant dislocations. Further, studies have shown that the metallic debris caused by the friction of these implants is causing metallosis, an allergic reaction that causes the tissues surrounding the joint to darken or turn black and often causing tumors in the area surrounding the implant. While not conclusive at this point, other studies suggest that this metal wear debris can affect organs away from the implant itself, as both Cobalt and Chromium (the elements which make up the implants) can be hazardous to humans, and in some cases are considered carcinogenic. You can read more about the problems with metal-on-metal implants HERE.
The Depuy ASR Cup was cleared by the FDA in 2005 via a process known as the 510(k) approval process. This process allows a manufacturer to obtain market approval with very little clinical testing of the device. All the manufacturer has to argue is that the device is “substantially equivalent” to a device that is already on the market, and they can get approval. For more information about the 510(k) approval process versus the more rigorous PMA process, click HERE.
If you or a loved one believes that they may have a Depuy ASR hip implant and would like more information, please contact us immediately for a fee consultation.
Hip resurfacing has recently become a very popular alternative to total hip replacement. Proponents argue that it is a less invasive procedure that preserves more healthy bone. However, the differences between total hip replacement and hip resurfacing are not as dramatic as one might think. In this video Dr. Ball explains the differences between the procedures and helps us to understand the risks and benefits of hip resurfacing…
