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Recalled Stryker and DePuy Hip Implants May Cause Serious Health Risks

Recalled Stryker and DePuy Hip Implants May Cause Serious Health Risks

Although hip replacements can often help individuals live with their disabilities, some products can lead to serious health complications and can put the patient in danger. Compared to older ceramic and plastic models, the metal-on-metal models were supposed to be more stable, less prone to dislocation, and longer-lasting. However, two popular hip replacement manufacturers, Stryker Corporation and DePuy Orthopedics, issued recalls within the last few years for metal-on-metal devices due to high early failure rates and serious health effects.

In 2011, the FDA instructed producers of metal-on-metal hip implants to conduct studies of patients who received the devices to determine whether the implants are shedding high levels of metallic debris. This year, the FDA issued an updated public health communication stating that MoM devices “have unique risks in addition to the general risks of all hip implants.”

Metal-on-metal hip devices have been a source of debate over the past few years, as research has linked the implants to serious risks such as the following:

  • Metallosis (build-up of metal debris in soft tissue of the body)
  • Implant loosening
  • Device failure
  • Pain
  • Prolonged swelling
  • Need for revision surgery.

Stryker Recall

In June 2008, the FDA approved Stryker’s Rejuvenate system, and the ABG II system received FDA approval in November 2009. Both systems were approved through the FDA’s 510(k) Premarket Notification Process, which allows a drug or medical device to be offered to the public without having to undergo clinical trials. The drug or product, however, must be substantially similar to a product that has already received FDA approval.

In April 2012, Stryker issued an Urgent Field Safety Notice for Corrective Action for its Rejuvenate Modular Stems and Necks. The company noted that there were potential risks associated with fretting and corrosion at the modular neck junction. Deterioration or corrosion at this junction may lead to increased metal ion generation in the surrounding joint space and can potentially cause damage to bone and/or soft tissue surrounding the implant and joint.

Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems in July 2012 due to the systems’ potential for fretting and corrosion. As of July 2012, there were 45 reports of adverse events from patients who say the devices caused pain and/or tissue swelling.

DePuy Recall

DePuy Orthopaedics, a division of Johnson & Johnson, created the ASR XL Acetabular Hip System and the ASR Hip Resurfacing System for younger, more active patients.

In 2009, the FDA confidentially notified DePuy that it was turning down the company’s application to sell the resurfacing device in the United States. Agency reviewers found problems with study data submitted by DePuy to support its claim that the artificial hip resurfacing system was safe and effective. The FDA requested added safety data if DePuy wanted to pursue its application. The product’s sister model, the ASR total hip replacement, received FDA clearance in 2005 through a different regulatory procedure that did not mandate clinical studies of the device.

According to the FDA, on August 24, 2010, “there was a voluntary recall of the DePuy ASR TM total hip system because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.” The FDA has received nearly 17,000 reports of problems with the implants, which sometimes require patients to undergo invasive surgery to receive a replacement device.

If you or a loved one has suffered a needless, catastrophic injury as a result of Stryker or DePuy hip replacement systems, the attorneys at Newsome Melton LLP can help you seek the compensation—and justice—you and your family deserve.

J&J Hip Replacement Lawsuits Consolidated, Will Be Seen By One Judge

J&J Hip Replacement Lawsuits Consolidated, Will Be Seen By One Judge

According to Bloomberg News, a judicial panel recently decided that all of the pretrial proceedings in federal lawsuits against pharmaceutical giant, Johnson & Johnson, over their recalled hip-replacement systems will be overseen in Ohio by one federal judge.

The news source reports that U.S. District Judge David A. Katz will “supervise evidence-gathering efforts in cases over the ASR XL Acetabular System, which J&J’s DePuy Orthopaedics unit recalled on Aug. 26 after the implants stopped functioning properly.”

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Over 10,000 Patients May Require Second Hip Replacement Surgery

Over 10,000 Patients May Require Second Hip Replacement Surgery

DePuy Orthopedics, a subsidiary of pharmaceutical and chemical company Johnson & Johnson, may be held responsible legally and financially for tens of thousands of hip revision surgeries, the UK Daily Mail reports. The company sold 93,000 hip replacement devices between 2003 and August 2010, when the company instituted a recall. Out of those 93,000 devices, about 12 percent will probably fail, according to a Fox News article.

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DePuy’s Defective Hip Replacement Devices Wreak Havoc On Patient’s Lives

DePuy’s Defective Hip Replacement Devices Wreak Havoc On Patient’s Lives

In the midst of all the legal reports and descriptions of symptoms experienced by patients in class action and multi-district litigation suits against DePuy Orthopedics, individual patient experiences can get lost in the shuffle. However, it is this personal suffering that led to the lawsuits in the first place. While important to stay aware of the larger issue, DePuy must be held accountable for the suffering caused by its devices.

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DePuy Allegedly Says Patients Liable For Surgery After Hip Recall

DePuy Allegedly Says Patients Liable For Surgery After Hip Recall

In September, we reported on Gulf War veteran Scott Almhjell. Almhjell was one of 93,000 people who had undergone hip replacement surgery to have a DePuy hip device implanted. Shortly after surgery he began suffering agonizing pains. He discovered in August that the hip device he was implanted with was recalled by DePuy for a high rate of failure. DePuy responded to his request for reimbursement by telling him he was responsible for his own injuries and denying his claim.

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DePuy Hip Recall Draws Massive Legal Attention

DePuy Hip Recall Draws Massive Legal Attention

Over 93,000 patients around the world received a DePuy ASR hip replacement implant between 2003 and 2010. In August of 2010, DePuy issued a recall of the devices after massive amounts of evidence demonstrated a much higher than average failure rate – 13% in the first five years after surgery – in the recalled devices. A few lawsuits against DePuy were filed even before the recall began. Now, a few months into the recall, the number of hip replacement lawsuits increases almost daily.

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Depuy Hip Recall Prompts Medical, Legal Attention

Depuy Hip Recall Prompts Medical, Legal Attention

Surgeons in Ireland, Australia, and all over the United States are calling for much more thorough and efficient monitoring of hip implants after DePuy Orthopedics announced a massive recall of its ASR hip replacement devices in August 2010. The recall came after mounting evidence began to show 13% failure rate for the devices in less than five years after having them implanted.

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Hip Recall Lawsuits Claim DePuy Knew Of Defects

Hip Recall Lawsuits Claim DePuy Knew Of Defects

The question in many minds after hearing of the DePuy ASR hip replacement recall is Why did DePuy continue selling the devices in America two years after pulling them from the Australian market for defective parts and materials? That is a question DePuy will have to answer in court. Many people who experienced problems with their hip implants before the devices were recalled in August 2010 didn’t even know the problems were due to the implant itself.

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