Risk and Complications with Stryker Hip Rejuvenate and ABG II Implants

Symptoms of Hip Complications

Hip replacement surgery is a procedure performed for the treatment of severe hip arthritis. For patients who have hip arthritis that is interfering with their normal activities and has not been adequately treated with non-surgical treatments, a hip replacement surgery may be a good option. However, research shows that hip replacement systems has been associated with risk and complications.

Metallosis is a rare condition that is caused by the buildup of metallic debris in the soft tissue of the body — in this case the soft tissue surrounding the hip joint.  It is more often seen in hip resurfacing patients than in total hip replacement patients. Metal debris from metal-on-metal hip implants can cause grey discoloration of the tissue surrounding the implant, usually indicating that the tissue is oxygen-starved and dying. The effects of metallosis can be particularly acute in implant recipients who have a condition known as metal sensitivity. several hip replacement complications, including:

Hip Replacement Complications

• Severe joint pain

• Implant failure

• Implant loosening

• Local tissue necrosis (tissue around the implant dies)

• Deterioration of the bone around the implant

• Formation of cysts or pseudotumors

• Osteolysis.

Over 8,000 hip Implant Patients Told Their Hip Device May Need To Be Revised

Johnson & Johnson, a multinational manufacturer of pharmaceutical products, is confronted with a multi-million pound claim. According to reports, thousands of implant patients in the United Kingdom have been informed that their hip replacement surgeries needed to be reversed. They claimed that the company's ASR hip replacement systems were defective, causing problems for many patients.

Ever since their hip replacement surgery, several implant patients with ASR hip devices complained of severe pain and difficulty walking. This led a number of them to file a class action lawsuit against DePuy Orthopaedics, the orthopedic division of Johnson & Johnson. The class action lawsuit might cost the manufacturer around 350 million pounds.

Over 5,000 implant patients have been called back to their hospitals to have their hip replacement devices checked. These patients are being checked for problems related to the hip systems, such as tumors and heavy metal poisoning.

Implant recipients who had DePuy's faulty hip devices reportedly suffered from severe pain, which resulted from the corrosion of the hip device components. According to reports, the metal components released tiny metal particles as they wear, causing inflammation and tissue damage.

Medical experts say that metal particles are normally present in the human body. However, test results show that recipients of DePuy's ASR hip replacement systems have extremely high levels of metal in their systems. Moreover, the test results of some patients showed that the metal levels in their blood were a hundred times higher than normal.

Sylvia Docherty, an implant recipient from Stockton-on-Tees, has been in pain ever since her hip replacement surgery. Back in May 2005, she was diagnosed with arthritis. After struggling to walk for a long time, her physicians advised her to undergo hip replacement surgery. At that time, DePuy's ASR hip device seemed to be her best option.

However, after the hip replacement surgery, Docherty suffered severe pain on the hip area. She claimed that the hip device damaged the soft tissue surrounding her hip. Moreover, based on her report, high levels of chromium and cobalt were found in her blood. She stated, “My mobility has been so bad it feels as if my life has been put on hold.”

Reports of complications associated with the ASR hip systems started to surface following its market release. After several concerns were raised, DePuy Orthopaedics recalled its ASR hip replacement systems. However, for some individuals, the recall came too late. As a result, several hip replacement lawsuits were filed. Moreover, many injured patients who have not yet filed a claim have approached personal injury lawyers for assistance. Additionally, information on lawsuits against hip device manufacturers may be found on law firm websites, such as the Rottenstein Law Group's www.rotlaw.com.

MDL Defective DePuy ASR Lawsuit Slated in U.S. District Court for Northern Ohio

Lawsuits filed by a number of recipients of recalled DePuy ASR hip implant manufactured by DePuy Orthopedics, a Johnson & Johnson subsidiary, are being consolidated under a federal district court judge in Ohio.

Under Judge David Katz, the multi-district litigation on DePuy ASR lawsuit is scheduled to be held in the U.S. District Court for Northern Ohio. 

Putting several cases into one litigation makes it possible for lawyers of different plaintiffs work together and share discovery issues and evidences. It is the same process that was instituted in the litigation involving BP Oil.

“Based on Judge Katz’s experience with other MDLs, we expect that he will do a good job of pushing these cases along, whether it be by settlement or trial. Any existing cases filed in various federal courts around the country will likely soon be transferred to his court in order to begin litigation in his court,” One of the lawyers said in a prepared remarks.

In August, DePuy Orthopedics based in Indiana recalled its ASR XL Acetabular and ASR Hip Resurfacing systems following mounting reports of a higher-than-normal number of patients requiring surgeries to correct or remove defective implants.  Affecting 93,000 people, the recall was prompted by fresh data from the National Joint Registry of England and Wales.  According to a DePuy press release announcing the recall, the report showed “a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System,” 

In June, a Florida woman accused the company of knowing about the device’s problems but failed to warn doctors. Thus, the first DePuy ASR lawsuit was born over the allegedly defective ASR devices. Three more lawsuits by California residents – who all had to have revision surgery after the implant partially detached from their hip sockets – followed the lawsuit days later.

By March, DePuy discontinued manufacturing the cup and had it phased out.  The company also sent letters to doctors that same month.  The letter warns that information from the Australian Medical Device Registry reflect a “higher-than-expected” failure rate in traditional hip replacements.  The data is especially true in smaller patients or those with weak bones.

According to the New York Times, these developments came after two years of reports gathered, showing that the implant was prone to early failure. The director of the Australian database, Dr. Stephen Graves, told the newspaper that the DePuy was quite sluggish in pulling the device off the market. The Times also reported that the Food & Drug Administration was in receipt of approximately 300 complaints about the ASR cup since 2008. Most complainants are currently undergoing revision surgeries to correct the device. Furthermore, the device’s co-developer, Dr. Thomas Schmalzried, said he and DePuy officials have come to realize that the ASR cup might be more of a challenge to implant properly than competing cups.

In 2005, DePuy introduced the ASR in the U.S. after obtaining a 510(k) clearance from the Food & Drug Administration for the device.

Alabama Plaintiff Files Lawsuit Against Rejuvenate Hip Manufacturer

Laray Johnson, a hip implant patient from Alabama, filed a lawsuit against Stryker Orthopaedics on December 06, 2012. According to him, the company is guilty of fraud, manufacturing defect, and negligence.

Johnson has replaced his hips with Stryker Modular Rejuvenate hip replacement devices. He claimed that the implants caused him severe pain and other complications. He filed the Stryker hip lawsuit in the Superior Court of California.

Lawsuit Filed Six Month After Stryker Hip Recall

The plaintiff, Laray Johnson, filed the lawsuit against the manufacturer of Rejuvenate hip replacement systems, Stryker Orthopaedics, six months after the voluntary product recall. The manufacturer issued the recall on June 12, 2012. According to the vice president of the company, Stuart Simpson, “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action.”

Moreover, according to reports, “Johnson’s lawsuit relates to the development, testing, assembling, manufacture, packaging, labeling, preparing, distribution, marketing, supplying, and/or selling of the allegedly defective Rejuvenate hip replacement, which includes the ABG II Modular stems, ABG II Modular necks, and Rejuvenate Modular Neck and Stem components.”

The Superior Quality of Stryker Modular Hip Replacement Systems

The Rejuvenate Modular hip replacement system, the latest model of the Secure-Fit and OmniFit hip devices, was introduced in the market by Stryker Orthopaedics in February 2009. According to the company, “the Rejuvenate hip system was developed to optimize anatomic restoration by providing options that offer enhanced stability, proven modularity, an intra-operative flexibility.”

Compared to traditional hip devices, the company stated that the design of the modular hip system was superior in durability and functionality. Unfortunately, Laray Johnson and several other implant patients who suffered complications associated with the hip device thought otherwise.

Several Lawsuits Filed Alleged Manufacturer of Fraud and Other Counts

The Alabama plaintiff, Laray Johnson, underwent hip replacement surgery on his right hip on March 22, 2011. After replacing his right hip, he underwent yet another hip replacement surgery on his left hip on June 24, 2011. Both hips were replaced with the Stryker Rejuvenate Modular hip replacement device a year before the product recall. Following the hip replacement surgeries, Johnson experienced severe pain and discomfort in the hip area.

Aside from Johnson, many other hip implant patients with defective rejuvenate hip devices have accused Stryker of negligence, manufacturing defect, deceit, concealment of vital information, and breach of the Consumer Legal Remedies Act. Information on Stryker lawsuits can be found on personal injury law firm websites, such as the Rottenstein Law Group's rotlaw.com.