Hip replacement surgeries remove all or a portion of a hip joint that has been damaged or corroded. An artificial hip joint is used to replace the hip joint. Unfortunately, the hip implant may be defective, which is bad news for the patient having surgery. The Stryker Rejuvenate hip implant is one type of hip replacement thought to be faulty.
Marketing for the hip implant device emphasized how unique it was from other hip replacement options. As opposed to previous hip devices, it is not a metal-on-metal device.
Instead, it has a ceramic component designed to replace conventional metal components. It was advertised to younger patients who needed hip replacements as having a longer lifespan and better range of motion.
Is a Stryker Rejuvenate Hip Replacement a Defective Item?
Many persons with the Stryker implant device reported experiencing metallosis after the implant was placed. A tissue reaction to heavy metals in the body results in metallosis.
It may lead to:
- Pain
- Failed hip implants
- DNA changes in the individual
- Limited mobility
- Blood toxicity problems
- Bone deterioration
- Chromosomal irregularity
- Tumors
The Stryker implant was ultimately voluntarily recalled. This indicates that Stryker, the implant’s manufacturer, chose to remove it from the market independently of being required to do so by a regulatory body like the FDA.
For What Reasons Did Stryker Recall the Rejuvenate and ABG II?
Prior to the recall, Stryker published a safety notice informing healthcare professionals that Rejuvenate and ABG II had a high rate of unfavorable local tissue reactions based on post-market data. ALTR describes issues brought on by tissue inflammation close to the implant.
According to Stryker’s official recall notification dated July 6, 2012, the business made the decision to recall the hip replacements after receiving the unsettling information.
The Rejuvenate and ABG II stems are coated with titanium, while the neck parts are comprised of chromium and cobalt. The neck and stem might rub against each other, causing metallic particles to be shed into the body.
The field safety alert listed several problems the items could cause:
- Fretting and corrosion at the modular neck connection and elsewhere can displace too much metal into the tissue.
- Metal ions can cause inflammation in the tissues around them, triggering an immune reaction that results in metallosis (metal poisoning), necrosis (death of tissue and bone), and discomfort that necessitates more surgery.
- Metal sensitivity patients may experience a severe allergic reaction that necessitates revision surgery.
A revision operation could be necessary if there is too much metal debris in the joint area since it might cause osteolysis, often known as bone loss.
In 2012, the U.S. Food and Drug Administration received numerous reports of negative implant-related events. Even if they had not experienced any negative effects, specialists at the time advised everyone who had gotten the implants to think about getting their blood tested for cobalt and chromium levels.
Processing Recalls Using Broadspire Care Management
To gather data and handle claims pertaining to the Rejuvenate and ABG II recall, Stryker contracted Broadspire Care Management. On its website, Stryker stated that it would cover patients’ out-of-pocket medical expenses related to the implants, including any revision surgeries required to get rid of the implant.
A third-party risk management organization called Broadspire focuses on managing medical case management, liability claims, and workers’ compensation claims for big businesses. Its involvement in a prior hip implant recall prompted doubts about how implant manufacturers handled hurt patients.
One year prior to the Stryker recall, DePuy, a different maker of hip implants, went to Broadspire. The business managed patient claims for out-of-pocket medical expenses for those who had gotten faulty DePuy hip implants.
In most cases, the implant manufacturer pays the patient’s claims and leaves the decision of whether or not to replace the implant up to the patient’s own physician.
However, under the Broadspire agreement, the insurance company’s doctors decided whether or not an implant needed to be changed.
To obtain medical permission forms for patients with hip implants, Broadspire and DePuy mailed documentation to certain doctors along with offers of $50 cash for each packet that was completed.
Critics asserted that Broadspire might use its position to obtain patient medical records and other data that might later be used against them in court if they brought cases related to their defective implants.
When Stryker hired Broadspire to handle the Rejuvenate and ABG II Modular-Neck Stem recalls, the privacy issues were brought up once more. Again, there were worries that patients would unintentionally give up legally protected constitutional rights.
Thousands of people who had problems with their ABG II and Rejuvenate hip implants ultimately sued Stryker, and the business settled the majority of these cases in 2014.
On August 29, 2016, the FDA announced a Class II recall for the LFIT Anatomic COCR V40 Femoral Heads. When the public notification was published on November 9, 2016, the FDA reported that the malfunction’s root cause was still being looked into.
If a Stryker Implant Caused Me Harm, Am I Allowed to Sue Them?
Depending on your specific situation, you might be able to hold Stryker accountable for creating a defective device that caused you harm. A product is deemed defective if it injures someone as a result of a manufacturing, design, or warning defect. Numerous sources claim that the Stryker hip implant device, in this case, had a design flaw that may have led to harm to the person filing the lawsuit.
A product’s design flaw, such as one that makes it more likely to lead to metallosis, happens when there is a weakness in how the product was created.
The court may grant a damages award in these actions to compensate for the person’s injuries brought on by the hip implant. Medical costs, lost wages, and these damages may cover other costs and losses for the injured party.
What Would Happen If You Were Hurt by the Stryker Rejuvenate Hip Implant Following the Recall?
Even though the Hip Implant was recalled in 2012, you may still be able to sue the company if you’re currently using one and get hurt.
The voluntary recall won’t prevent you from being compensated, and if a class action lawsuit has already been resolved, a fund will probably be available to replace your losses.
You or your loved one’s estate or heirs are entitled to bring a lawsuit on their behalf if they had one, were hurt by it, and ultimately passed away (either from the implant or anything else unconnected).
It’s critical to demonstrate that either you or a loved one has the implant and was harmed by it. Your case will be aided by any medical records that contain the implant number or details about the operation.
The court might also ask to see your medical history in order to determine whether you had any experiences that could have contributed to the harm, such as getting hit by a car after getting the implant and the implant breaking as a result.
How Can I Tell if I Have a Case?
A malfunctioning implant can have long-lasting effects on your body, and you might need to file a lawsuit to get paid for your suffering. To find out if you have a case for defective items, speak with a defective products attorney. The attorney can outline your rights and offer you suggestions and legal counsel specific to your case.
