Stryker Rejuvenate Hip Replacement Implant Recall Lawsuit
Stryker Rejuvenate Hip Implant Lawsuits
On January 25, a Stryker Rejuvenate class action lawsuit was filed in a south Florida federal court seeking free treatment and medical monitoring for people implanted with the recalled metal hip replacement devices. Michigan-based Stryker Orthopedics recalled its metal Rejuvenate Modular hip implants in June 2012 following widespread reports of metal poisoning, local tissue reactions, pain, premature device failure, and early modular-neck junction corrosion attributed to its design defects. The FDA received as many as 60 complaints on the hip implant failure, metallosis, infection, and bone necrosis in the four months preceding the recall.
An estimate released by Stryker Orthopedics in January 2013 puts the total costs the manufacture has to pay for personal injury lawsuits filed following the hip system recall at $390 million.
The number of Stryker Rejuvenate hip lawsuits is expected to rise in the months ahead as more patients are coming forward seeking compensation for injury, pain, side effects, suffering caused by the device and reimbursement for medical and implant costs. In January 2013, the Supreme Court of New Jersey ordered for consolidated proceeding of all Stryker hip product liabilities filed in the state courts.
Stryker Rejuvenate Hip Implant: The System and Drawbacks
Stryker Rejuvenate hip implants were introduced in the United States in February 2010 following
authorization through the FDA’s controversial 510(k) approval process. The procedure, which is being subject to strong criticism, permits introduction of new drugs or medical devices “substantially equivalent” to similar products already approved by the FDA for marketing and consumer use. Stryker introduced the Rejuvenate hip implants claiming that the system was similar to Profemur hip implants produced by Wright Medical Technology in design and offered superior intraoperative efficiency and flexibility.
The Stryker Rejuvenate hip implant system consists of the following three components
- A chromium-cobalt stem
- A non-metallic ball
- A titanium neck
The design of Stryker Rejuvenate hip implant system has been found defective and causes rubbing of metal components of the system against each other that discharges metal particles into the blood stream, putting users at the increased risk of metal poisoning. Many patients using these metal artificial hips have been diagnosed with high blood chromium and blood cobalt levels. Continuous and unusual fretting disables the metal parts early, and the devices last less than a quarter of the 15-year life span claimed by the manufacturer. Metal particles released from the artificial hip implants also cause infection, bone necrosis, and scar tissue and pseudotumor formation in and around the hip area.
The Wring Profemur hip implants with which Stryker Rejuvenate systems share design similarity have been subject to many lawsuits for their early failure, loosening of implants, consistent hip pain, and problem in walking or standing.
Stryker Rejuvenate Hip Implant: Major Side Effects
- Metallosis and toxicity
- Thyroid disorders
- Cardiovascular problems
- Hip area inflammation
- Metal poisoning leading to nervous system, gastrointestinal, cognitive disorders, vision and hearing problems, skin rashes, myocardiopathy, hypothyroidism, and death
- Sharp rise in cobalt and chromium ions in blood
- Peripheral soft tissue damage
- Nerve palsy and other side effects impacting normal nervous system functioning
- Device dislocation and chronic pain
- Premature device failure leading to secondary or revision surgery
- Bone necrosis and fractures
Stryker Rejuvenate Hip Implant Warnings
More than 17,000 complaints have been made through the FDA adverse reporting system, highlighting side effects and failure of metal hip implants in the last one decade. In May 2011, the FDA asked all metal artificial hip implant manufacturers, including Stryker, to conduct comprehensive safety assessment of its products fully reflecting safety concerns of consumers raised through complaints to the regulator.
In April 2010, just two months after the FDA approved Stryker Rejuvenate hip implants through 510(k) clearance and without adequate testing, the British national health agency cautioned against using metal-on-metal hip devices, citing lower than average life span, pain, surrounding tissue damage, metal poisoning, and high rate of revision surgery. It followed a research report where scholars from the University of British Columbia warned that metal hip implants could increase blood cobalt level by 10 times and blood chromium by at least twice, putting users at a significant risk of metal poisoning.
Stryker Orthopedics, a leading manufacturer of artificial hip devices, has been in the news for implant defects since early 2005 when the FDA received complaints about premature failure of its acetabular, femoral, and restoration hip implants. In 2007, the FDA twice admonished Stryker for unhygienic conditions and detection of Staphylococcus bacteria at its plant manufacturing hip implant systems.
In January 2008, Stryker recalled Hemispherical cups and Acetabular PSL hip implant components following discovery of more than permitted “manufacturing residuals” in them. In March 2009, the American Academy of Orthopedic Surgeons advised users to avoid Stryker artificial hip systems, citing excessive squeaking problems associated with its hip implants. In April 2012, the UK Medicines and Healthcare Products Regulatory Agency recommended against using Stryker femoral stems along with DePuy MITCH hips, citing increased risk of metal poisoning.
Stryker Rejuvenate Hip Implant Lawsuits
The filing of Stryker Rejuvenate lawsuits has been on the rise following its market withdrawal in 2012. Stryker Orthopedics has already earmarked a fund of $390 million to settle personal injury claims arising out of Rejuvenate hip system recall.
A lawsuit filed in a Florida federal court on January 25, 2013, calling for free medical monitoring and treatment of all Florida residents who have received Stryker Rejuvenate hip implants, has sought class action status. The plaintiff, a native of Florida, was implanted with the hip system in July 2011, a year before the manufacturer issued the recall. He now needs to undergo regular tests to ascertain the likelihood of side effects that can adversely affect his health and lifestyle. The lawsuits demand a special fund by Stryker to finance free medical monitoring of hundreds of people in Florida implanted with Stryker Rejuvenate hip implants.
A dozen of Stryker Rejuvenate lawsuits have been filed in January 2013, seeking compensation from the manufacturer on the ground of product liability. Four of these lawsuits filed in a Minnesota district court have alleged that Stryker erred in adequately researching on safety aspects of the Rejuvenate implant design and failed to inform consumers about the risk of potential complications. More than a dozen of Rejuvenate hip implant lawsuits are awaiting trial in New Jersey.
Another Stryker Rejuvenate lawsuit filed in December 2012 in a Florida south district court claimed that the manufacturer delayed in recalling the hip implants or warning consumers and healthcare professionals about the potential risks associated with them. The lawsuit alleged that Stryker failed to implement post-marketing measures on safety concerns despite reports and complaints highlighting complications caused by Rejuvenate hip implants.