Stryker Rejuvenate and ABG II modular-neck hip stems Lawsuit
Stryker Lawsuit, Stryker Rejuvenate Lawsuit, ABG II modular-neck Lawsuit, Stryker hip stems Lawsuit
In June 2012, Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems. While modular-neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, Stryker decided to voluntarily recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.
Stryker also bypassed clinical trials to quickly get their product on the market. If an orthopedics company wants to put a new kind of device into circulation, it needs to first pass the FDA’s Premarket Approval process. This is a highly stringent approval process that requires extensive clinical studies. In the Medical Device Amendments of 1976, the FDA split regulatory classes for medical devices into three different categories, called Class I, Class II and Class III.
Hip replacement implants are classified as Class III, meaning they have the highest impact on human life and should therefore have the highest level of regulation and oversight.
According to the FDA, a Class III device is one that “supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury.”
Unfortunately, there is a way around the FDA’s testing requirements. Instead of going through the Premarket Approval process, Stryker was able to get their device approved by submitting a 510(k) “premarketing submission.” This essentially tells the FDA that the device is similar enough to other devices on the market that it shouldn’t need to go through the approval process again. The device is able to get approved on the basis that other similar products are on the market and have a good track record. Using a 510(k) submission, Stryker is able to bring their implants to market with only post-market surveillance. In other words, they don’t need clinical trials, but they do need to keep tabs on how their implants affect patients. The downside with this approach is that problems can only be spotted once they show up in real patients.
Symptoms Associated with the Rejuvenate and ABG II Failure:
- Metal poisoning
- Hip dislocation, loosening, or premature implant failure
- Nerve damage around the hip
- Pain, or limping as a result of pain
- Misaligned implant (determined by x-ray)
Surgeons should consider performing a clinical examination, such as blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling. Repeat follow-up examination, such as blood work and cross-section imaging, should be considered even in the presence of normal initial findings. Stryker suggests that patients who have received a Rejuvenate or ABG II modular-neck hip stem contact their surgeon to schedule a follow-up appointment even if they are not experiencing symptoms such as pain and/or swelling at or around their hip. Patients who have received a Rejuvenate or ABG II modular-neck hip stem contact their surgeon to schedule a follow-up appointment even if they are not experiencing symptoms such as pain and/or swelling at or around their hip.
Stryker Hip Lawsuit Claims
People who filed Stryker lawsuits accuse the company of selling and marketing a defective device and failing to warn the public, among other claims. They also claim that Stryker was negligent because it failed to adequately design the Rejuvenate and ABG II hip devices to ensure that they would not deteriorate, fret or corrode. The lawsuits claim the following:
- Stryker failed to warn surgeons and patients that the Rejuvenate and ABG II modular systems can cause heavy metal poisoning.
- Stryker misrepresented that the devices would not corrode or fret, when in fact they did so in many patients, some of which fretted within days of implantation.
- Stryker used deceptive marketing practices.
- Stryker claimed, falsely, that the Rejuvenate and ABG II were safe alternatives to metal-on-metal bearing devices.
- Stryker failed to remove the defective products from the marketplace after reports of early failure.
- Stryker continued a normal course of selling and marketing after they knew that their titanium alloy fretted and/or corroded when implanted with cobalt-chrome components.