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FDA Orders Studies on Hip Implant Metallosis Risk

Federal regulators have ordered manufacturers to conduct post market studies to determine the health effects of artificial hip implants.

As reports of metal poisoning from hip replacement systems grow, federal regulators have ordered manufacturers to conduct post market studies to determine the health effects of artificial hip implants. Metal-on-metal hip devices account for approximately 30% of the hip replacements performed each year around the country, and concerns have been growing that these products are fundamentally defective and prone to a number of extremely serious side effects.

DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.

Hip Implant Recall Update 7/10/12: Michigan-based Stryker Orthopaedics is now recalling two brands of devices used in conjunction with artificial hips in hip replacement surgeries. To date, the devices in question – the Stryker Rejuvenate and ABG II Modular-Neck Stem – have been linked to at least 45 adverse event reports (AERS) submitted to the FDA by individuals who claim to have suffered severe pain and/or tissue swelling. Click here for more information.

Free Metal-on-Metal Hip Implant Case Evaluation: If you or a loved one has been injured by a defective hip implant device, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

May 12, 2011 – Last week, the U.S. Food & Drug Administration (FDA) announced that it was seeking data about the potential risk of metal poisoning from metal-on-metal hip implant systems.

As concerns grow about the levels of cobalt and chromium shed by these devices, FDA is ordering manufacturers to conduct followup research on patients to see what health effects the implants may have. In all, FDA sent a total of 145 post marketing surveillance orders to 21 different manufacturers including DePuy Orthopedics, Zimmer, and Stryker. When completed, the studies will include information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal the devices actually shed, and what the potential side effects are.

Metal Poisoning (Metallosis)

As metal-on-metal hip components rub against each other, metallic particles may be shed into the body around the implant site, resulting in a condition known as metallosis. Complications arising from metallosis may include:

  • tissue damage
  • inflammatory reactions
  • bone loss
  • genetic damage
  • aseptic fibrosis
  • local necrosis

In October 2010, the American Academy of Orthopedic Surgeons (AAOS) issued a warning about the risk of metallosis from metal hip implants. AAOS indicated that doctors and patients should be aware that side effects such as pain months after surgery could be a sign of metallosis.

Hip Replacement Side Effects

In addition to the risk of metallosis, a number of other problems with metal-on-metal hip systems have been identified which have resulted in devastating pain and additional surgeries. Many individuals who have received metal-on-metal hip implant devices have reportedly suffered:

  • unexplained hip pain more than three months after hip replacement
  • loosening of their artificial hip implant
  • hip replacement revision surgery

Which metal-on-metal hip implants have been found to be defective?

  • Johnson & Johnson hip replacement devices – ASR™ XL Acetabular System and the ASR™ Hip Resurfacing System – In August 2010, DePuy Orthopeadics issued a nationwide recall of these devices. The recall came after over 300 complaints were received describing device failure since 2008. Since then, a slew of lawsuits have been filed nationwide and many more are expected in the near future.
  • Wright Profemur hip system – Problems with this type of implant could cause failure in a very short period of time. This may result in severe pain and the need for additional hip revision surgery.
  • Zimmer Durom Cup – Multiple surgeons around the country have reported a higher than expected rate of failure and loosening of the Zimmer Durom Cup, often requiring painful secondary surgery. In 2008, Zimmer suspended sales of this device.

To date, hundreds of lawsuits have been filed around the country on behalf of of individuals injured by metal-on-metal hip implant devices. Because many hip replacement patients are unaware of the type of implant used, cases are being investigated for any individuals who have experienced problems after a surgery since 2006.

Do I have a Metal-on-Metal Hip Implant Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in metal-on-metal hip implant lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

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