What Stryker Hips Have Been Impacted by the FDA Recall, and how do I Know if I Have one?
Rosenfeld Injury Lawyers LLC represents people impacted by the Stryker hip FDA recall who were injured by a faulty medical device or medical malpractice after undergoing replacement hip and knee implant procedures. 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 Food and Drug Administration.
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 Stryker Howmedica Osteonics Corporation is a leading manufacturer of artificial hip replacement devices and other medical implants. However, in 2012, the US Food and Drug Administration (FDA) pushed the manufacturer to voluntarily recall every Stryker Rejuvenate and ABG II artificial joint replacement device due to thousands of complaints from patients who had undergone joint replacement surgery. Since 2016, the United States, Australia, the United Kingdom and Canada initiated country-specific recalls of the LFIT Anatomic V40 device.
Since the initial recall, health care professionals were notified of the voluntary recall action taken by Stryker who cited the device's dangers. Since then, the FDA has urged patients who underwent Rejuvenate or ABG II and LFIT Anatomic V40 implant surgeries to contact their surgeon to discuss their need for a revision procedure.
The defective hip implant injury attorneys at Rosenfeld Injury Lawyers LLC provided the facts posted below to assist families in making a better-informed decision list when seeking justice and taking legal action to obtain the compensation they deserve for their injuries.
Recalled Artificial Stryker Hip Systems
Over the last decade, the FDA issued mandatory recalls, and Stryker voluntarily recalled many of their hip replacement products that include:
- Rejuvenate – Many patients received the Rejuvenated model manufactured with six stands and sixteen modular necks. The Stryker Corporation marketed the Rejuvenate to a younger audience that tends to be highly active, suffering a decreased range of motion and experiencing hip pain.
- ABG II – Stryker manufactured and marketed the ABG II with ten modular necks, eight left stems, and eight right stems so surgeons could adapt the device to fit the patient's femur and pelvic bones. This hip replacement device was designed to improve stability while minimizing stress on the femur bone.
- Stryker LFIT Anatomic V40 – The company designed and manufactured the LFIT Anatomic V40 surgical total hip replacement procedure. This device is used in conjunction with the Stryker Citation, Meridian, Accolade II and Accolade TMZF.
Why the Recalls Were Necessary
Officials at the Stryker Corporation initiated a worldwide recall of the Rejuvenate, ABG II and LFIT Anatomic V40 Femoral Head due to serious problems including corrosion, metal poisoning, taper lock failures and other issues. Many patients experienced an adverse local tissue reaction (ALTR) that eventually led to severe side effects and life-threatening medical complications in the months and years after the individual had undergone an initial total or partial Stryker joint replacement surgery. Many of the problems associated with defective Stryker implants involve:
- Increasing pain in the abdomen, groin and implant area
- Hip instability
- Toxic metal poisoning (metallosis) that resulted from joint component grinding that caused metal dust, particles, and fragments to enter the patient's bloodstream
- Hip joint noises including grinding, squeaking, popping and clicking sounds
- Limited mobility and decreased range of motion
- Hip dislocation
- Broken hip stem trunnion
- Excessive wear and tear producing metallic particles and debris
- A loss of bone fixation strength in the implant
- Difficulties when standing or walking
- Swelling of the affected joint site
- Shortened neck length
- Deficiency in soft tissue
- Nerve damage
- Swelling and pain at the hip joint
- Dead (necrotic) bone tissue (osteolysis) dissolution (bone loss)
- Weakening pelvis and femur bones
- Bone fractures surrounding the artificial hip joint
- Muscle atrophy caused by immobility
- The need for revision surgery
Since the Stryker Howmedica Osteonics Corporation first released their hip implant devices to the medical marketplace, the FDA has received hundreds of reports of adverse events involving the Rejuvenate, ABG II, and Stryker LFIT Anatomic V40 products.
Metal Poisoning Remains a Serious Concern
The voluntary action by Stryker to recall their most popular hip implant devices from the medical marketplace is due in part to health concerns over metal poisoning (metallosis). Most Stryker hip implant devices are manufactured with chromium and cobalt that are now known to create serious health hazards when the grinding action of the moving joint releases metal ions and particles into the patient's bloodstream.
The long-term medical consequences of dangerous CoCr ions and particles have yet to be identified. However, many patients have suffered severe toxicity reactions, horrific inflammation in the necrotic (dead) destruction of the tissue surrounding the implant. Elevated levels of cobalt particles in the patient's bloodstream are known to cause thyroiditis, peripheral sensory nerve damage, cranial problems, and systemic immune response issues.
Canadian and Australian FDA Agencies Got Involved
In September 2016, Healthcare Canada, the Canadian equivalent to the Food and Drug Administration issued a Stryker implant recall alert. This notification identified problems previously identified by the FDA with the Stryker LFIT Anatomic V40 femoral head hip implant components used in conjunction with other devices.
Healthcare Canada stated that the device manufacturer “has received higher than expected complaints of taper lock failure for specific lots of certain sizes of the LFIT Anatomic CoCr V40 femoral head devices manufactured [before] 2011.”
In 2016, the Australian government released a public warning stating that the Stryker LFIT Anatomic V40 recall would be imminent after receiving complaints about the manufacturer's devices. The Hazard Alert identified that many of their citizens had experienced adverse events that were associated with the Stryker hip plant replacement parts stating that the company “has a higher than expected incidence of taper lock failures.”
The LFIT Anatomic V40 recalls occurring in Australia, Canada, and the United States involved implant failure on specific devices that include:
- LFIT Anatomic V40 Femoral Head (36 mm & 44 mm)
- Accolade 2 Implant Devices
- Accolade TMZF Implant Devices
- Meridian Implant Devices
- Citation Implant Devices
The company recognizes the serious concerns involving taper lock failure that are known to pose significant health problems for patients who have undergone previous hip surgeries. Many of these patients develop bone fractures, device separation, bone death (necrosis) and metallosis (blood poisoning) caused by foreign metal particles, debris, and substances released into the individual's bloodstream.
How did This Happen?
The Stryker Howmedica Osteonics Corporation chose to obtain FDA approval for their devices through the expedited 510(k) Premarket Notification Process on the three products that were eventually voluntarily recalled. This expedited process sidesteps the traditional, and more difficult, approval process through the Food and Drug Administration that requires rigorous testing, scientific evidence and clinical trials to identify problems before the devices are sold in the medical marketplace.
The medical device manufacturer used a loophole in the law to gain approval by designing “substantially similar” devices that had already been approved by the federal agency. Unfortunately, bypassing clinical trials and rigorous testing before selling the product to consumers can create disastrous outcomes, like those that have happened in marketing, promoting and selling the Rejuvenate, ABG II, and Stryker LFIT Anatomic V40 without comprehensive testing.
As a result, patients became unwitting guinea pigs that were used to identify the life-threatening health hazards associated with Stryker devices. These hazards included developing metallosis, suffering broken bones, experiencing nerve damage, losing their hip stability, experiencing increased pain at the affected site and many more develop medical conditions.
The timeline of Stryker hip implant failures involves:
- April 2008 – The device manufacturer submitted their Rejuvenate hip replacement devices to the Food and Drug Administration under the expedited 501(k) Premarket Notification Process.
- June 2008 – The federal agency approved the application determining that the Rejuvenate was “substantially similar” to other products that had already been approved for sale and use.
- August 2009 – Stryker Howmedica Osteonics Corporation submitted their ABG II Modular-Stem devices to the FDA under the expedited 501(k) Premarket Notification Process for approval.
- October 2009 – The federal agency approved the Stryker application determining that the ABG II Modular-Stem devices were “substantially similar” to other products that it already been approved for sale and use.
- February 2010 – The manufacturer began marketing the Rejuvenate hip replacement devices to surgeons, hospitals, and medical centers.
- April 2012 – The FDA notifies Stryker of serious concerns involving the Rejuvenate system. The manufacturer then issues an immediate “Urgent Safety Alert” to inform surgeons of the potential serious side effects when implanting the device in their patients.
- July 2012 – The Stryker Corporation issued a voluntary recall of every Rejuvenate and ABG II devices in the United States not already implanted in a patient. Stryker initiated a voluntary recall with the cooperation of the Food and Drug Administration.
- 2012 and 2013 – Patients injured by defective Stryker artificial hip replacements higher attorneys begin filing lawsuits and compensation claims to recover monetary damages.
How do I Know if I am Affected?
If you underwent an orthopedic surgical procedure involving implant or joint replacement, there are records to determine the device used during your surgery. The doctor, surgeon or hospital likely listed in your medical records the manufacturer, name, model and the serial number of the product used in your procedure.
Avoid waiting until you begin suffering the painful complications and severe side effects associated with defective medical devices. Instead, discuss what you can do now with your doctor to improve your health, safeguard against life-altering consequences and the need to undergo implant revision surgery. If you choose to wait, it could be too late to avoid developing life-threatening complications associated with defective Stryker artificial hip implant devices.
How are Patients Responding?
Since 2009, many patients have filed civil lawsuits and compensation claims against Stryker Howmedica Osteonics Corporation claiming that they suffered severe harm and life-threatening conditions after their surgery. Since then, Stryker has paid plaintiffs more than $1.4 billion in attorney negotiation meetings (out of court settlements) and jury trial awards involving the Rejuvenate and ABG II artificial hip implant devices. This amount was paid out to resolve more than 4500 lawsuits.
Many believe that thousands of more individuals who have yet undergone revision surgeries or experienced severe health consequences will likely file lawsuits and compensation claims soon.
What do I do now?
If your loved one has suffered severe side effects after receiving a Stryker hip implant device, their injuries might be the result of medical negligence or defective medical device. 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. Our law firm has successfully prosecuted many Stryker hip implant injury cases involving devices recalled by the FDA.
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 claim 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.
We provide every client a “No Win/No-Fee” guarantee, meaning if we are unable to secure financial compensation through a negotiated out of court settlement or a jury trial award, you owe us nothing. All information you share with our law office in discussing your case remains confidential.
For additional information see the following pages:
- 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?
- Is it true that Stryker hip systems can cause metal poisoning, and if so, what types of metals are contained in the Stryker hip implants?
- 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?