Burns, TN: Ewell was given a Stryker Rejuvenate hip when he had hip replacement surgery in late 2008, shortly after it was approved. He has been in agony ever since.

“The pain started immediately after surgery,” says Ewell. “I went back to my surgeon
three times over the first year and had multiple x-rays. He said that the pain was due to scar tissue from surgery and after a while it would go away. It never did.”

Now Ewell is concerned that his replacement hip is one of the models in the Stryker Orthopedics Rejuvenate Modular Hip System Recall. Since the Rejuvenate Modular Hip System and ABG II Modular-Neck stems recall in July 2012, many Stryker recall lawsuits have already been filed against the manufacturer by plaintiffs. Ewell is also worried that the pain may be due to metallosis—an adverse tissue reaction to heavy metals in the body.

There is mounting evidence that metal-on-metal hips are defective, and thousands of lawsuits have been filed by people who have metallosis, muscle damage, and total hip replacement failure. Ewell may be experiencing more than just ‘scar tissue’.

(Although the Stryker Rejuvenate is not a metal-on-metal hip device, the neck piece is metal. Under certain conditions this piece has reportedly rubbed against the metal stem, which caused metallic debris to come loose and can lead to metallosis.)

“My hip hurts more now than before I had the Stryker replacement,” says Ewell, age 65. “I’m retired and trying to build a new house—I have more time than money since retiring—but this hip is really slowing me down. Nine years later, I can’t lift anything more than about 30 pounds.”

After those three visits to his surgeon, Ewell gave up—he certainly wasn’t getting any answers. “Each time I saw my surgeon he said there was nothing wrong,” Ewell adds. “I never had a hip replacement surgery before so I didn’t know what to believe–except what I was being told. But six years ago I had a quadruple bypass surgery and had to go to cardiac rehab. I got talking to other people who had hip replacement without any pain or discomfort. They didn’t have a Stryker Rejuvenate though. Seems that in the past few years the pain gradually gets worse and the more physical labor I do, the worse it gets.

“Sometimes the pain keeps me awake at night and it wakes me up a few times during the night. I roll over and over and can’t get comfortable. I spoke to my family doctor–my surgeon has retired. He just said I need to go back to the bone and joint clinic and explain my problem to them. So that is my next step.

“I’m frustrated but I know there is nothing I can do until I go to this clinic. But I need to finish my house first for financial reasons. If I need a revision surgery, I may be even worse off; I can tell you that it isn’t getting any better.”

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No early link between all-metal hip implants and cancer-study

09/14/2012

By Debra Sherman

Sept 14 | Sat Sep 15, 2012 1:05am IST

(Reuters) – All-metal hip implants, which have been shown to have high failure rates and cause a host of other health problems, were not linked to cancer seven years after implantation, new data show.

Concerns have grown in the medical community that the so-called metal-on-metal hip implants shed metal particles through wear on their ball-and-socket structure. Many patients who have received the devices have had elevated levels of cobalt and chromium particles detected in the bloodstream, leading some doctors to worry about their risk of developing cancer.

Johnson & Johnson and Stryker Corp have recalled several models of all-metal implants because of high failure rates — meaning the patient needed another surgery to fix a problem, such as dislocation — and set aside billions of dollars to cover patient claims. Neither company was immediately available to comment. Since the recalls, the use of all-metal implants, which were sold as being more durable, has declined sharply.

“Some basic science and some epidemiological studies have suggested that metal-on-metal hip replacements may be associated with an increased risk of developing cancer after total hip replacement and specifically with an increase in malignant melanoma and haematological, prostate, and renal tract cancers,” the UK National Joint Registry (NJR) said in its annual report, which was released this week at the British Orthopaedic Association meeting in Manchester, UK.

The NJR, which collects data on joint replacement surgery and monitors the performance of the implants, said it used UK National Health Service Hospital Statistics data to test whether metal-on-metal hip implants are associated with an increased risk of cancer in the early years after hip replacement, compared with other surfaces, such as metal-on-polyethelene.

The NJR said it found no association seven years after implantation but that the devices should continue to be tracked as many cancers can take longer to manifest themselves.

“Due to the age of the NJR we could only assess the risk for the first seven years after hip replacement and are happy to report that we could not identify an increased risk of developing cancer,” the NJR said.

“We must, however, point out that many cancers have prolonged latency after initial exposure to carcinogens and thus long-term follow up is needed to provide a definitive answer,” it added.

NO U.S. TRACKING MECHANISM

Hundreds of thousands of people have all-metal hip implants. Since the recall, J&J faces thousands of lawsuits over the failure of its ASR model, which was pulled from the market, and more lawsuits tied to its Pinnacle all-metal device, which is still being used.

The United States has no independent registry tracking the performance of medical devices over time, and health regulators are still discussing how manufacturers should follow up on complaints over the all-metal implants.

The U.S. Food and Drug Administration has been monitoring problems with all-metal hip implants and convened a panel of outside advisers earlier this year to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

Last year, the FDA ordered implant manufacturers to conduct follow-up studies in cases in which an implant’s failure could have serious consequences. Companies were ordered to take blood samples from patients to measure metal ion levels. That analysis has not been completed.

The NJR said its latest analysis continues to support conclusions it drew last year showing markedly higher failure rate with metal-on-metal implants.

In addition to J&J and Stryker, makers of all-metal hip implants include Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc.

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Lawsuits over hip implants filed against Stryker in Texas, New Jersey

Published: Thursday, September 13, 2012, 10:10 AM     Updated: Thursday, September 13, 2012, 10:12 AM

By Yvonne Zipp | yzipp@mlive.com

KALAMAZOO, MI – Seven plaintiffs filed lawsuits against Stryker Orthopaedics, formerly Howmedica Osteonics Corp., over its recalled Rejuvenate and ABG II hip implant systems.

The law firm of Searcy Denney Scarola Barnhart & Shipley PA announced Sept. 11 that it had filed the suits in Bergen County Superior Court in New Jersey. The South Florida law firm also filed the first case against Stryker in August on behalf of a Boca Raton, Fla., woman. The plaintiffs allege that Stryker negligently developed, tested, manufactured, distributed, marketed and sold its defective Rejuvenate System.

A Stryker spokeswoman declined to comment on the lawsuits. “As a matter of company policy, we do not comment on legal matters,” Jeanine Guilfoyle said in an e-mail Thursday.

The Kalamazoo-based medical device maker voluntarily recalled the metal-on-metal modular hip implants in July. At the time, Stryker said it issued the recall and halted global production due to elevated risks of fretting or corrosion that “could result in adverse local tissue reactions manifesting with pain and/or swelling.” About 20,000 of the recalled devices were sold in the United States.

Separately, a Texas corrections officer filed suit against the company in the U.S. District Court of Texas over the hip implant, Injury Lawyer News reported Sept. 12. In that case, filed July 5, the plaintiff was implanted with Stryker’s Alumina Ceramic V40TM Femoral Head device, which, the lawsuit alleged, dislocated three times in two weeks. That case was filed in federal court because the plaintiff’s claim of complications is in excess of $75,000.

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Weitz & Luxenberg Files First Case Involving Injuries Caused by Recalled Stryker ‘Rejuvenate’ and ‘ABG II’ Hip Implants

PRWeb

Monday, August 20th 2012

Weitz & Luxenberg will lead the national litigation against the manufacturer of the recalled Stryker Othropaedics product. Ellen Relkin, a lawyer in Weitz & Luxenberg’s defective medicines and devices unit, urged patients injured by this product to contact the firm.

New York City (PRWEB) August 20, 2012

The law firm of Weitz & Luxenberg, P.C. today announced that it is investigating and prosecuting cases involving patients who suffered harmful effects from either of two now-recalled artificial hip systems made by New Jersey company Howmedica Osteonics, also known as Stryker Orthopaedics.

“We are interested in hearing from individuals implanted with the Stryker ‘Rejuvenate’ or the Stryker ‘ABG II’ hip implant systems,” said Weitz & Luxenberg, a preeminent mass-tort and personal-injury litigations law firm that, over the years, has secured some $7.3 billion in verdicts and settlements for its clients. “We represent patients who have been terribly injured by these artificial hips within months of undergoing the strenuous total hip arthroplasty, only to learn that they need to have it removed and replaced, going through an even more difficult and painful surgery and rehabilitation.”

The devices were voluntarily recalled last month by their manufacturer.

Weitz & Luxenberg said it had filed the first case in the country involving the recalled hip implant stem (Pingel v. Stryker Orthopaedics, Sup. Ct. N.J.), and would be working alongside the Florida law firm of Searcy, Denney, Scarola, Barnhart & Shipley, P.A., counsel to the Pingels, to lead the Rejuvenate litigation.

Since Stryker is a Bergen County, New Jersey-based company, cases from plaintiffs around the country may be filed and centralized there, according to the firm.

Weitz & Luxenberg, through its offices in New York City and Cherry Hill, New Jersey, has won impressive verdicts in New Jersey state courts for victims of defective medications including the landmark $13.5 million verdict in McDarby v. Merck (Sup. Ct. N.J, Docket No. A-0076-07T1), the only Vioxx verdict in the country to be upheld on appeal, and a recent $9 million verdict for Accutane victim Kathleen Rossitto (Sup. Ct. N.J., Index # ATL-L 7481-10).

The firm also represented numerous plaintiffs in a prior litigation involving a different Stryker hip product, (Sup. Ct., N.J., In re: Stryker Trident Hip Implant Litigation) and was the court appointed liaison counsel to that centralized litigation.

Scientists have observed that under certain conditions the metal stem in these Stryker hips can corrode or fret, or both, causing metal ions to be deposited on surrounding tissues and give rise to adverse localized reactions. Weitz & Luxenberg’s Ellen Relkin, co-lead of the Multi-District Litigation for the DePuy ASR hip implant (MDL #2197), said this device can release high level of cobalt and chromium ions into the bloodstream and produce adverse reactions. These dangers are present, Relkin said, even though unlike the DePuy ASR, Biomet Magnum and Wright Conserve Cup, the Stryker Rejuvenate is not a metal-on-metal articulation device.

Relkin said that recipients of Stryker Rejuvenate implants had reported adverse local reactions including bone dissolution, inflammation of the synovial membrane, pseudo-tumors, stained metal tainted fluid in the joint and necrosis (death) of tissue, bone and muscle.

In April, Stryker Orthopaedics – a division of Stryker Corp., of Kalamazoo, Mich. – reacted to the corrosion and fretting risk of the Rejuvenate product by issuing an “urgent safety alert,” Weitz & Luxenberg said. Meanwhile, Canada required Stryker Orthopaedics to issue a so-called “revised instruction for use,” the firm added.

“This recall occurred in July,” Relkin said. “Patients who received an implant between April and July are rightfully angry, since the ‘safety alert’ did not prevent the use of the implant nor did it meaningfully prevent the injuries these patients may endure in the near future.

“The initial Rejuvenate line has been on the market since at least early 2009, and it received FDA approval in 2008.”

Weitz & Luxenberg said that Rejuvenate qualified for U.S. Food and Drug Administration approval under a fast-track process available to products that are “substantially equivalent” to those already greenlighted for sale by the FDA under standard rules of scrutiny.

“If you or someone you know has received a Stryker Rejuvenate hip implant that failed or is causing pain, please contact Weitz & Luxenberg today to discuss your options and let us answer any questions you may have,” the firm urged.

About Weitz & Luxenberg:

Founded in 1986 by attorneys Perry Weitz and Arthur Luxenberg, Weitz & Luxenberg, P.C., today ranks among the nation’s leading law firms. Weitz & Luxenberg has secured more than $6.5 billion in verdicts and settlements for its clients. The firm’s numerous practice areas include: asbestos and mesothelioma, defective medicines and devices, environmental pollutants, accidents, personal injury, and medical malpractice. Victims of accidents are invited to rely on Weitz & Luxenberg’s more than 25 years of handling such cases – begin by contacting the firm’s Client Relations department at 1-800-476-6070 or at clientrelations@weitzlux.com and ask for a free legal consultation. More information: http://www.weitzlux.com

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/8/prweb9809504.htm

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Complications of Stryker Rejuvenate & ABG II Modular-Neck Hip Stems

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ABGII Modular Femoral Stem and Modular Neck – hip replacement system

Product recall & cancellation

 20 July 2012

 The Therapeutic Goods Administration (TGA) advises that Stryker Australia Pty Ltd is recalling the ABGII Modular Femoral Stem and Modular Neck system used in hip replacements.

This recall is occurring worldwide because of the potential for fretting and corrosion at the join between the femoral stem and the neck component of the ABGII Modular System. Fretting and corrosion can result in metal debris in and around the hip joint. If this occurs, patients may experience inflammation, adverse local tissue reactions (ALTRs), hypersensitivity/allergic reactions and osteolysis (bone loss). The worldwide rate of complaints received by the manufacturer related to ALTR as well as unexplained pain, in relation to the total number of implanted components is less than 0.5%.

The TGA has been advised that 258 ABGII Modular Femoral Stem and Modular Neck systems have been implanted in Australia since 2007. None have been implanted since February 2012.

Stryker Australia Pty Ltd has contacted every Australian orthopaedic surgeon who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate.

The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG).

ABGII femoral implants with fixed (non-modular) necks are not being recalled.

About the Stryker ABGII Modular Femoral Stem and Modular Neck

ABGII Modular Femoral Stem and Neck system
(The femoral head is shown in the photograph
but is not included in this recall)

About the Stryker ABGII Modular Femoral Stem and Modular Neck

The ABG II Modular Femoral Stem and Modular Neck is a modular hip replacement system that consists of two components:

• a neck, and
• a stem.

The stem is inserted into the patient’s femur and the neck is then inserted firmly into the femoral stem. The neck is supplied in a variety of lengths and angles, allowing the surgeon to adjust the hip prosthesis during the operation.

Information for patients

If you are experiencing hip or thigh pain, or are concerned about your hip replacement, please contact your implanting surgeon to arrange a review appointment.

If you are NOT experiencing hip or thigh pain and are not concerned about your hip replacement then it is not necessary for you to do anything. Just follow the normal follow up schedule agreed between you and your surgeon.

Information for orthopaedic surgeons

Stryker Australia has written to all Australian orthopaedic surgeons who have implanted the ABGII modular hip replacement system and advised that:

• Surgeons should ensure that their patients who have been implanted with an ABG II modular hip replacement system are followed-up regularly and undergo clinical evaluation as per their usual protocol.
• If a patient is experiencing pain and/or swelling involving the groin, buttock, lateral hip or thigh, the surgeon should rule out aseptic loosening or periprosthetic sepsis, common conditions following joint replacement surgery that are not related to an ALTR to metal wear debris.
• Once the surgeon has ruled out aseptic loosening and periprosthetic sepsis, the surgeon should evaluate the patient for an ALTR potentially related to metal wear debris. Testing includes blood work for metal ion levels chromium and cobalt levels over 7 ppb are commonly considered high) and either an MRI or ultrasound to look for soft tissue mass or fluid collection.
• If the results reveal an ALTR to metal wear debris, the surgeon should consider proceeding with a revision of the femoral component to a monolithic stem.

Information for all health professionals

Patients with any hip replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if the patient complains of pain and other symptoms associated with their hip implant and surgery.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Please refer to the TGA Internet site for more information on the TGA Incident Reporting and Investigation Scheme (IRIS).

You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

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