Articles Posted in Defective Hip Implants

Metal-on-metal Pinnacle hip recipients who experienced metal poisoning may be eligible to file a hip replacement lawsuit to seek compensation.

Johnson and Johnson (J&J) issued a hip replacement recall in 2010 that affected its popular DePuy ASR total hip replacement system. J&J made the decision after receiving reports about higher than expected early failure rates. A large number of patients were required to undergo a hip revision surgery after being diagnosed with metal poisoning. The grinding of the metal-on-metal components caused the device to corrode and infect the bloodstream with metal debris.

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Pennsylvania personal injury lawyer, Thomas Anapol, who was instrumental in negotiating the November 2014 Stryker hip replacement lawsuit settlement, will continue to pursue Stryker hip lawsuits throughout 2015.

A voluntary Stryker hip recall was issued in July 2012 after the company received reports of metal poisoning caused by the device corroding inside the body. As a result, patients were required to have a hip revision surgery.

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A Stryker hip replacement lawsuit settlement was reached in November 2014, but lawyers continue to file Stryker lawsuits on behalf of recipients of failed metal-on-metal Stryker hip implants.

Stryker Orthopedics recalled its Rejuvenate and ABG II hip implants in 2012. The Stryker hip recall was announced after a number of patients were required to undergo a revision surgery after suffering metal poisoning from debris in the blood stream caused by the metal hip components grinding together.

The November Stryker settlement will include patients who had a failed Stryker Rejuvenate or ABG II and had a revision before November 3, 2014.

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In November 2013, a $2.5 billion settlement was proposed for recipients of the recalled DePuy ASR metal-on-metal hip implant. Individuals who received the DePuy Pinnacle hip replacement are not entitled to compensation under the ASR settlement, but injured patients from all over the country are now filing DePuy Pinnacle lawsuits.

Like the ASR, recipients of the DePuy Pinnacle have experienced metal poisoning as a result of device corrosion, and many have required a hip revision surgery.

Johnson and Johnson recalled the DePuy ASR in 2010, but the company did not issue a Pinnacle recall. Instead, it discontinued the sale of the metal-on-metal Pinnacle device in August 2013.

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Anapol Weiss Shareholder Thomas Anapol successfully assisted in negotiating a global settlement involving Stryker Rejuvenate and ABG II modular recalled hips, which was announced on November 3. The global settlement is the largest base award with enhancements for metal hip implant settlements.

The Stryker settlement comes on the heels of the Biomet settlement, which was announced in February 2014. Anapol Weiss hip implant lawyer Thomas Anapol was an instrumental leader in both the Stryker and Biomet litigations. Anapol served as Co-Lead counsel in the Biomet litigation and served as one of only four attorneys on the Stryker Negotiations Committee.

The Stryker hip replacement lawsuit settlement will provide plaintiffs with a base award of $300,000 per implant. Recipients who experienced complications during a revision surgery or suffered additional damages may be eligible for additional compensation. Compensation will also be provided to patients who need a revision surgery but are medically unable to undergo the procedure.

On August 27, NBC10 interviewed Tom Anapol and his client-a victim of metal hip implant failure-about the physical complications and the device’s inadequate premarket testing.

In addition to the physical and emotional pain that metal-on-metal hip patients have endured, there is another disturbing part of the situation. Johnson and Johnson had the implant approved under the 510(k) process, which does not require human testing before implanting the device in patients.

The side effects of the metal-on-metal hips can be life threatening. In Lorenz’s case, a blood test showed very high levels of cobalt and chromium in his bloodstream. “The ball and the cup actually grind together and shed particles into the bloodstream, and that’s what happened to him specifically,” Anapol explained.

According to the Lancet, which has a prestigious heritage as one of the world’s leading medical journals striving for medical excellence in all that they publish, there is great concern because of soft tissue reactions to metal debris caused by metal on metal hip replacement implants.

European orthopedic associations such as the National Joint Registry of England & Wales and the Dutch Orthopaedic Association have encouraged follow up for patients who have metal on metal hip replacement implants and even go as far as advising against the use of all metal on metal large head hip implants.

Other recommendations include to summon all patients who have had metal-on-metal replacements in the past to an annual check-up, for at least the next five years at least and to include assessment of cobalt ion concentrations in blood and x-ray diagnostics.

According to a recent article in the New England Journal of Medicine, more than 500,000 patients in the United States have received metal-on-metal hip implants, most of which were implanted between 2003 and 2010. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip implants made from other materials.

On June 27-28, 2012 the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee seeking expert scientific and clinical opinion on the risks and benefits of metal-on-metal hip systems including:

• Failure rates and modes;

On July 6, 2012, Stryker Orthopaedics voluntarily recalled two hip implant components used in several of their total hip replacement systems. The recalled parts include all lots of the Rejuvenate Modular and the ABG II modular-neck hip stems. A modular hip stem attaches to an artificial hip replacement to help the hip replacement fit better with each individual patient’s anatomy. The hip stem is composed of a modular stem with a modular neck designed for use with compatible femoral heads and their compatible acetabular components.

Stryker issued this particular recall because of concerns about wear and tear and corrosion. During the first half of 2012, at least 45 adverse events were reported to the FDA. The problem is patients can experience pain and swelling in the tissue around the implant. Here are some adverse events from the MAUDE database:

–Doctor has 10 patients who have a potential metal sensitivity to the Rejuvenate modular stem/neck.

Is the FDA system broken? Manufacturers of hip implant medical devices don’t have to go through clinical trials like prescription drugs. All these metal on metal hip implant makers have to do is – to establish that the hip implant is substantially equivalent to other devices already on the market in order to gain approval.

That’s good news for the billion-dollar medical device makers and their investor relations but bad news for people like you who need hip replacements and the doctors who implant them. It doesn’t take much to get a hip replacement on the market. Does it practically take an act of God to get the device removed from the marketplace?

Something is terribly wrong when a dangerous medical devices like metal on metal hip implants are introduced and marketed over and over again with the same set of flaws and side effects or worse set of flaws and side effects.

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