URGENT BULLETIN: DEPUY ASR XL HIP CUP FINALLY RECALLED

August 30th, 2010

On Thursday, August 26, 2010, DePuy Orthopaedics, (a division of Johnson and Johnson), finally announced they would recall the DePuy ASR XL Hip Cup. The DePuy ASR Cups failed earlier than anticipated causing implant patients to undergo asecondary revision surgery.

The DePuy Hip Implant models under recall are:

  • DePuy ASR XL Acetabular System
  • ASR Hip Resurfacing System

These implant statistics total approximately 93,000 worldwide and the implant mechanisms were discontinued in 2009. These types of implants were made popular with younger patients whom, under surgeon’s recommendation, were fitted with these implants for better stability and less risk of dislocation post-op.

DePuy said it intends to cover “reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.”

Patients must understand that this does not address the pain and suffering they have endured due to the implantation of this defective device. 

DON’T JUST CHOOSE ANY LAW FIRM.  CHOOSE THE RIGHT LAW FIRM.

If you or a loved one have had a hip replacement including the DePuy ASR XL Hip Cup being recalled by DePuy, contact us right away.  Keefe Bartels has been litigating knee and hip implant cases like the DePuy ASR Hip Recall for over a decade.  We have litigated cases against all of the major hip implant manufacturers, including Depuy, in courts across the nation, and have recovered millions of dollars on behalf of patients injured by defective knee and hip implants such as the Depuy ASR.  

All consultations are 100% free of charge.  You will speak to an experienced attorney about your rights when you contact us.  Don’t be lured into contacting some national marketing firm that will screen your case and then refer your case to someone you do not know.  Ask them who will be handling your case, and ask to speak to that attorney.  Ask how many hip recall cases they have handled.  Ask them if they have litigated against DePuy previously.  Ask them what kind of recoveries they have gotten for their clients.  The right attorney is the crucial first step for you in recovering your quality of life and recovering for your injuries suffered due to the defective and recalled DePuy ASR Hip Cup. 

Please fill out the contact us form today and you will receive a call from an attorney in our defective implant department within 24 hours.  You can also call us 24 hours a day, 7 days a week at 877-ATTY-24-7.

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Posted in Emerging Legal Issues, General Information, Hip Recall Lawsuit, Hip Replacement News, Knee Replacement News, Uncategorized, Wright Medical, hip recall, hip resurfacing | No Comments »

New Study Raises Doubts about Artelon CMC Spacer

July 20th, 2010

Artelon CMC Spacer

A recent large study conducted by leading hand surgeons in Sweden reveals that the Artelon CMC spacer may be the wrong choice for patients who are struggling with osteoarthritis at the base of the thumb.

The study was conducted over a 1-year period at 7 different clinics and casts doubt on earlier research which had suggested that the Artelon CMC spacer would produce results better than those of traditional osteoarthritis treatment methods. Top surgeons now say that the Artelon CMC spacer does not produce these superior results. In fact, the spacer may lead to additional pain, swelling and even infection, possibly necessitating revision surgery to remove the faulty spacer.

The Artelon CMC spacer is a tiny T-shaped component that is surgically inserted into the carpometacarpal (CMC) joint at the base of the thumb. The surgical implant is made from Artelon, a porous biomaterial that is supposed to aid in the growth of native tissue. The spacer acts as a treatment for osteoarthritis, a painful degenerative joint disorder that affects nearly 27 million adults in the United States.

Since 2005, the Swedish company Artimplant AB has marketed the Artelon CMC spacer in the United States through the U.S. company Small Bone Innovations. Artimplant AB owns the Artelon patent and claims that the Artelon CMC spacer offers a treatment for osteoarthritis that is more effective than the traditional tendon interposition arthroplasty.

In 2005, doctors conducted an early pilot study on the effectiveness of the Artelon CMC spacer. That study was limited, however, to the patients at 1 clinic. The results suggested that after an Artelon CMC spacer was implanted, the patient’s “pinch strength [would be] statistically significantly greater than after tendon interposition arthroplasty.” However, a group of surgeons, some of whom had participated in the original research, have now determined that these earlier results were not completely accurate.

Patients who had received the Artelon CMC spacer were 29% more likely to present swelling. Moreover, due to substantial pain, 12 patients needed to have the spacer removed within 2 years of surgery.

The researchers used methods that included thorough patient selection, a large number of patients, and 7 hospitals. The surgeons monitored over 100 patients suffering from osteoarthritis.

The study notes that the “chemical and physical properties of the biomaterials themselves may lead to chronic inflammation whereas motion at the implant site by the biomaterial may also produce chronic inflammation.” Further, the study shows that the traditional well-proven method of tendon interposition arthroplasty, which is favored by a majority of hand surgeons, may still be the best option for patients suffering from osteoarthritis in the thumb.

If you or a loved one has been injured as a result of an Artelon CMC spacer or other medical device implant, please contact our office for a free consultation.

　

Source:  

Nilsson Anders, Wiig Monica, Alnehill Hakan, Berggren Magnus, Bjornum Sten, Geijer Mats, Kopylov Philippe, Sollerman Christer. The Artelon CMC Spacer Compared with Tendon Interposition Arthroplasty: A Randomized, Controlled, Multicenter Study of 109 Patients with Osteoarthritis Followed for 1 Year. Acta Orthopaedica 2010; 81: 239–46.

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Posted in Emerging Legal Issues | 2 Comments »

Wright Profemur Z Stem shows 11.2% Failure Rate – Where is the FDA???

June 24th, 2010

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, manufacturered 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. 

x ray of Wright Profemur Z Modular Hip System

Profemur Z X-Ray

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Posted in Emerging Legal Issues, General Information, Hip Replacement News, Wright Medical | 2 Comments »

Urgent – Depuy ASR Hip Cup Pulled From US Market

June 18th, 2010

Depuy ASR Cup

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.

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Posted in Emerging Legal Issues, General Information, Hip Replacement News | 4 Comments »

Hip Resurfacing vs. Total Hip Replacement

June 17th, 2010

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…

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Tips and Information for Maintaining Healthy Knee and Hip Joints

June 17th, 2010

Every year in the U.S., nearly 500,000 patients have one or more hips or knees replaced. Although the human body is resilient, our joints are actually quite fragile… Read the rest of this entry »

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Metal on Metal Implants – Important Risk Information

June 15th, 2010

Metal on metal hip implants account for approximately one-third of the 250,000 hip implants done in the United States annually.  However there is mounting evidence that these implants may be defective, and that these defects may cause a variety of serious problems in patients.  Data from joint registries confirms that metal on metal implants are more likely to fail and require a revision surgery than any other bearing interface. 

When a metal on metal hip implant is used in a total hip arthroplasty or a hip resurfacing surgery, the acetabular insert, which was typically made with a type of plastic known as ultra high molecular weight polyethylene, is instead made out of cobalt chromium, and articulates against a metal femoral head, which is also made of cobalt chromium. 

The problem with this type of interface is multi-factorial.  When hip or knee implant components move against each other, the friction causes wear.  This happens with any medical device implant, just as it occurs with your god given joints.  The body attempts to rid itself of this particulate debris by carrying the particles away in the lymphatic system.  However, the wear particles that are produced from a metal on metal implant may be detrimental to patients’ health in a number of ways.   Read the rest of this entry »

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Posted in Emerging Legal Issues, Hip Replacement News | 1 Comment »

Stryker Trident Hip Implant Litigation Centralized in New Jersey

June 14th, 2010

5/4/2009

(Update of 1/22/2009 Posting)

The New Jersey State Supreme Court has assigned all litigation of Stryker Trident hip implants to Atlantic County NJ and Superior Court Judge Carol Higbee for central management but has not yet designated it a mass tort. Stryker Corporation has faced manufacturing problems with its Trident PSL implant product line and issued a recall in the beginning of 2008. A number of patients have experienced problems and complications with their Trident PSL implants including improper fitting and functionality failures. In several cases, these complications have resulted in additional revision surgeries.

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Recent Hip, Knee, and Replacement Joint News

May 3rd, 2010

4/13/2009

Defective joint and product liability lawyers, Keefe Bartels & Clark have begun investigation of Wright Medical Technology Total Hip Implants

The defective joint implant attorneys at Keefe Bartels & Clark have begun investigating reports regarding total hip implants manufactured by Wright Medical Technology, Inc., a Tennessee Corporation. Wright manufactures and distributes orthopaedic implants including implants for the hips and knees. The FDA’s Manufacturer and User Facility Device Experience Database (MAUDE) indicates several reports regarding the failure of Wright Total Hip Systems that use the Conserve product line as well as the Profemur Product lines.

The defective product attorneys at Keefe Bartels & Clark are currently screening patients who had the Conserve Plus Cup and the Profemur Stem and/or Neck implants utilized in their total hip replacement and are experiencing problems or have experienced a device failure. In some cases, these components fracture, resulting in a “catastrophic” failure of the hip implant device. Other components may not promote, and may in fact, retard, bony ingrowth, resulting in the devices loosening and requiring additional surgery to repair or replace the failed component. These implants may have been designed or manufactured in a defective manner. If you believe you may have one of these hip implant components, and are suffering from pain, swelling, or limitation on your range of motion, or if you have had to have the hip implant revised, please contact the defective hip implant lawyers at Keefe Bartels & Clark immediately.

1/22/2009

New Jersey Court Announces Application for Mass Tort Designation of Litigation involving Stryker Trident Hip Implants and assignment for centralized management in Atlantic County, New Jersey.

Motion made for Mass Tort designation for Stryker Trident Hip System

Pursuant to New Jersey Court Rule 4:38A and the Revised Mass Tort Guidelines, application has been made to the New Jersey Supreme Court requesting that the claims made against Stryker Corp., and its subsidiary Howmedica Osteonics Corp., regarding the Stryker Trident Hip Implant System be designated a Mass Tort and sent to Judge Higbee in Atlantic County New Jersey for centralized management.

The Stryker Trident Hip Implant is a ceramic implant that has been the subject of numerous claims involving the hip implant making squeaking noises. This sound is caused by the high levels of friction at the acetabular interface of the implant. This condition can be an indicator of more serious problems with the implant in the future, and the hip implant attorneys at Keefe Bartels & Clark allege that these devices suffer from either a manufacturing or design defect which is resulting in the squeaking hip noise reported by some patients. If you or a loved one has a hip implant that is squeaking, please contact our office immediately.

Read the rest of this entry »

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