Archive for the ‘Emerging Legal Issues’ Category

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Update: DePuy Recalls Defective A.S.R. Hip Implant, But High Failure Rates Continue

Friday, February 4th, 2011

Depuy ASR Hip RecallThis 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.  (more…)

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Posted in DePuy, Depuy A.S.R. Hip Implant Recall, Emerging Legal Issues, Hip Recall Lawsuit, Hip Recalls, Hip Replacement News, Hip Resurfacing, Johnson & Johnson Company | No Comments »

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

Thursday, 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, 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.

x ray of Wright Profemur Z Modular Hip System

Profemur Z X-Ray

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Posted in Emerging Legal Issues, General Orthopaedic Information, Hip Replacement News, Wright Medical | No Comments »

Urgent – Depuy ASR Hip Cup Pulled From US Market

Friday, 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 DePuy, Emerging Legal Issues, General Orthopaedic Information, Hip Recall Lawsuit, Hip Replacement News, Hip Resurfacing, Johnson & Johnson Company | No Comments »

Metal on Metal Implants – Important Risk Information

Tuesday, 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.   (more…)

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Posted in DePuy, Depuy A.S.R. Hip Implant Recall, Emerging Legal Issues, General Orthopaedic Information, Hip Recall Lawsuit, Hip Recalls, Hip Replacement News, Hip Resurfacing, Johnson & Johnson Company, Knee Replacement News | No Comments »

Recent Hip, Knee, and Replacement Joint News

Monday, 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.

(more…)

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Posted in DePuy, Depuy A.S.R. Hip Implant Recall, Emerging Legal Issues, General Orthopaedic Information, Hip Recall Lawsuit, Hip Recalls, Hip Replacement News, Hip Resurfacing, Johnson & Johnson Company, Knee Replacement News, Uncategorized, Wright Medical | 1 Comment »

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