Rosenfeld Injury Lawyers LLC represents people with post-surgery injuries caused by medical malpractice from surgery including replacement hip and knee implant procedures and other types of professional negligence. Our law firm has extensive experience in resolving cases for our clients who have required revision surgery after receiving the defective implant that was voluntarily recalled by the device manufacturer or forcibly recalled by the FDA.
Our attorneys are available to answer any legal question on how to receive the compensation you deserve if a malfunctioning medical device injured your loved one. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
Stryker Implant Injury Information
The defective medical device injury attorneys at Rosenfeld Injury Lawyers LLC provide the facts concerning metallosis (metal poisoning) posted below. We offer this information to assist families in making a better-informed decision when seeking justice in taking legal action to obtain the compensation they deserve for their injuries.
In July 2012, the Stryker Corporation recalled their Rejuvenate and AGB II modular hip implant devices because of concerns involving corrosion and fretting. Back then, the FDA (Food and Drug Administration) had received hundreds of complaints that the modular neck junction was causing severe problems including ALTR (Adverse Local Tissue Reactions) where patients had developed metal poisoning (metallosis) and other complications. Some of these complications include:
- Necrosis, where tissue and bone die due to metal toxicity
- Pseudotumor where a fake tumor develops in the tissue surrounding the newly implanted joint
- Bone fractures caused by the weakening of bone tissue due to metal toxicity
- Skin rash
- Groin pain
- Adverse reaction to metal debris (ARMD)
- Aseptic, lymphocyte-dominated vasculitis-associated lesion (ALVAL)
- Nerve damage
- Destruction of the hip abductor
- The requirement for reconstructive or revision surgical procedures
- Thyroid issues
- Renal failure and other kidney issues
- Neurological problems
- Cardiovascular problems
- Vertigo and dizziness
- Depression, fatigue, and anxiety
- DNA disruption or damage
- Hearing and vision loss
- Brain fog
- Chronic headaches
- Gastrointestinal (G.I.) disorder
- Memory loss
Unfortunately, the metal surface area on a hip implant metal-on-metal design exposes the components of the device. Continuous joint movement can quickly elevate toxic levels of chromium and cobalt debris when moving parts rub together. Even tiny amounts of chromium and cobalt particles can make the patient sick. The effects of metal poisoning in some patients with an excessively high tolerance to generated metal ions are often not noticed until toxicity amounts have reached life-threatening levels.
What is Metal Poisoning?
Metal poisoning (metallosis) develops as a joint replacement side effect when the metal-on-metal components grind together, releasing metal particles and debris in the surrounding tissue. Stryker manufactures its devices from various metals including titanium, chromium, and cobalt. When the metal particles damage the tissue surrounding the joint, the tiny debris can enter the bloodstream and travel throughout the body.
Detecting Metal Poisoning
Hip replacement device manufacturers use the investing technology of metal alloys when fabricating artificial joints. These devices are typically constructed with various metals including chromium, nickel, titanium, and molybdenum. The implant parts including socket and ball or the stem and neck of the artificial hip joint can fail where the different metal alloys touch, rubber grind against each other during joint movement.
Metallosis sufferers often experience unexpected adverse reactions including total or partial deafness, auditory disturbances, blindness, anxiety, and depression due to an impact to the body's nervous system. The preliminary stages of metallosis (metal poisoning) are not always apparent, where doctors might treat the symptom instead of the cause. Without medical or surgical intervention, the implant failure in its initial stages can lead to deadly illnesses and the complete destruction of the hip replacement device.
Other indicators that something is wrong with the implant device typically include:
- A popping or grinding sound
- Skin reaction
- Cognitive impairment
- Psychological changes
- Vision and hearing damage
- Weakening heart muscle
- Cardiomyopathy (chronic heart muscle disease)
- Thyroid problems
- Excessive swelling near the implant joint
- Difficulty in walking
- Pain in the groin, hip, or leg
The Affected Hip Implant Devices
Many affected hip implant devices have been recalled from the medical marketplace due to their metal-on-metal construction and unexpected failure rate. Most of these recalled devices are manufactured by the Stryker Corporation, while others have been designed and sold by Depuy, Wright Medical and Zimmer. These devices include:
- Stryker Rejuvenate
- Stryker ABG II
- Stryker Accolade
- Stryker LFIT V40
- DePuy ASR
- DePuy Pinnacle
- Wright Medical Profemur
- Wright Medical Conserve
- Zimmer Kinetiv
- Zimmer ML
Over 8000 patients who have suffered severe adverse reactions caused by metallosis (metal poisoning) have filed lawsuits and compensation against the device manufacturers including Stryker, Wright, Zimmer, and DePuy. Our attorneys base our compensation lawsuits on design defects and severe side effects associated with metallosis and the need for revision surgery after the initial implantation. The allegations made by plaintiffs against leading artificial hip manufacturing companies include:
- A Defective Product Design – These lawsuits claim that the manufacturer knew or should have known that their products were defective and never should have released the devices into the medical marketplace.
- A Failure to Warn Patients and Doctors – The companies knew or should have known the potential risks of defective hip implant products and yet failed to warn patients and doctors of the severe, life-threatening concerns.
- Unethical Product Marketing – These companies intentionally misled doctors and consumers by using dishonest product marketing campaigns, placing profits ahead of patient safety and concerns.
- Insufficient Testing Procedures – Quickly bringing the devices to the medical marketplace required sidestepping the strict FDA approval process. As a result, the unsafe product was tested by the public instead of through clinical trials, causing thousands to suffer unnecessarily.
Voluntary Recall – Slow to Act
In 2012, the Stryker Corporation issued an Urgent Field Notice that warned doctors that the device could easily corrode and fret at the modular neck junction. The manufacturer stated that this failure could cause tissue necrosis and bone death, metallosis, and substantial pain. It took several months after issuing the Field Notice before the company ordered a voluntary recall of the Rejuvenate and ABG II, because of the significant problems that are now occurring in the Stryker Accolade, Stryker Meridian, Stryker Citation and LFIT V40 Femoral Head.
An FDA Recall
In 2012, the US Food and Drug Administration (FDA) issued a recall notice to publicize their concerns that the Stryker Rejuvenate hip implant had devastating health issues. Since then, the FDA has issued warnings on the Stryker Accolade, the ABG II, LFIT Anatomic V40 Femoral Head, Meridian TMZF, Citation TMZF and other devices because of cobalt and chromium toxicity. The federal agency noted that there was denigration to the device's structural integrity as it fails that then spreads microscopic metal debris throughout the body using the bloodstream.
The FDA claims that the metal-on-metal device can easily corrode, break, loosen, or dislocate, leading to osteolysis (bone loss), necrosis (tissue death) and metallosis (metal poisoning).
An article published in 2015 by the Association of Bone and Joint Surgeons revealed findings that the premature failure of these devices often led to junction corrosion of the femoral head and stem. The article stated that most patients experienced joint dysfunction, excessive pain, and life-threatening levels of metal poisoning that required the need for revision surgery to treat spontaneous horrific failures of the head and stem junction.
Preventing and Treating Metallosis
Some individuals have a high sensitivity to the metals used in hip implants including those who are allergic to nickel. Exposure to metal toxicity in the joint's surrounding tissue or bloodstream can cause severe complications including organ damage, bone and tissue death (necrosis) an implant failure that will require undergoing revision surgery.
Smokers are encouraged to participate in smoking cessation programs to avoid the potentially severe, life-threatening side effects created by defective hip implants. Smokers with metal-on-metal implants are at the highest potential risk of developing metal poisoning. The American Academy of Orthopedic Surgeons reported at the 2012 annual meeting that smokers had a metal-on-metal replacement device failure rate of 9.1%. This rate compares to non-smokers who have a 3.4% artificial hip joint failure rate.
Doctors usually treat the underlying cause of metallosis through revision surgery. The surgical procedure requires removal of the failing replacement device or its components from the patient's body, that are reconstructed or restored using implantable plastic or ceramic components. However, revision surgical procedure is often costly, hazardous, and has an extensive recovery, rehabilitation and recuperation timeline that is significantly longer than the patient's initial replacement surgery.
Your diagnosing physician will likely recommend you undergo various testing including a blood test, x-rays, ultrasound or MRI to help identify chromium and cobalt metal poisoning levels in your body. Your doctor might order these advance tests even if you are not sure you are suffering any symptoms. Seeking treatment before you received an accurate diagnosis could be significant because you might not be experiencing the physical indicators associated with metallosis. Often, the destructive properties of harmful metal debris can hide for months or years until the traumatic condition is realized.
If your doctor identifies the heightened level of metal toxicity in your bloodstream or you are suffering other complications associated with metallosis, you likely need to undergo hip revision surgery. During this procedure, the surgeon will remove your existing denigrating metal-on-metal implant and replace the device with a unit composed of ceramics or another product that does not have the potential of creating metal toxicity.
After your surgery, it is crucial that your attorney obtain and preserve the defective unit as evidence to support your claim for compensation. You can turn over the device to your attorney to keep it in safe storage until your case is settled during a negotiation meeting or you win your lawsuit at trial. Additionally, you need to ask the surgeon for the tissue damage images captured during the procedure that can provide additional supporting evidence.
Ready to File a Stryker Implant Lawsuit?
Your loved one might be the victim of a defective hip implant device injury or medical negligence. The product liability and medical malpractice attorneys at Rosenfeld Injury Lawyers LLC provide legal assistance to patients who have suffered injuries after undergoing surgical procedures. Time is of the essence. Your claim for compensation must be filed before the state statute of limitations expires. We currently offer legal representation through individual cases filed in state court and as a part of the multidistrict litigation process being handled in a Minnesota federal court.
Contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your compensation claim. Our legal team accepts all personal injury case, wrongful death lawsuit, product liability suits and medical malpractice claims through contingency fee agreements. This arrangement postpones the payment of legal services until after we have successfully resolved your case through a jury trial or negotiated out of court settlement. Our law firm offers every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf, you owe us nothing. All information you share with our law office remains confidential.
For additional information see the following pages:
- What Stryker hips have been impacted by the FDA recall, and how do I know if I have one?
- Have all Stryker hip implants been recalled, or just specific designs?
- Why have the Stryker Rejuvenate and ABG II Modular Hip Neck systems been recalled?
- What are signs that my Stryker hip implant has failed or is defective?
- Should I hire a lawyer for a case involving my Stryker hip implant?
- Will I be able to afford hiring a lawyer to represent me in a Stryker Rejuvenate hip implant case?
- What type of legal actions are available to recover funds from Stryker?
- Why should I consider hiring a lawyer as opposed to entering the Broadspire program to have my expenses paid?
- What are injuries associated with defective Stryker hip implants such as the Rejuvenate and ABG II?
- If I require a revision surgery due to my defective Stryker hip implant, may I still collect damages?
- What are the risks associated with a hip revision surgery?
- What are the design flaws in Stryker hip systems?
- What types of compensation may be available in my Stryker hip implant case?
- Does your law firm have any relationship with the Stryker Corporation?
- How can I find a lawyer to represent me in my Stryker hip implant case?