Failures And Flaws That Led To The Stryker Hip Implant Recalls
Like most people who have received an artificial hip, you may be wondering if your device is one of the implants making the headlines. Several manufacturers have initiated recalls and warnings about the failures of these devices, many of which have led to revision surgeries, including Stryker Orthopedics. Our attorneys want all patients to be fully aware of the risks of their hip implants, as well as have the information they need to get compensation for any dangerous side effects of a Stryker hip implant.
Why Were Certain Models of Stryker Hip Devices Recalled?
Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems in July 2012. Both of these devices are made using a variety of interchangeable neck and stem pieces, allowing surgeons to custom-fit the implant to the patient. With 16 different stems and 10 modular necks, the ABG II system was marketed as a way for patients to improve their joints with less stress on their bones, while the Rejuvenate’s 6 stems and 16 necks boasted advantages for younger patients who relied on a greater range of motion.
However, these devices could not deliver on their good intentions. Failures in the creation and design of these devices caused the need for major revision surgery less than three years after implantation, ultimately doing more harm than good for many patients.
After these devices were recalled, questions were raised about many different factors that could have led to unnecessary injury, including:
- Patented metal alloy. Both of these devices’ stems were made using a titanium alloy, a mixture of titanium, zirconium, molybdenum, iron, and other metals. Stryker’s propriety alloy mixture was supposed to resist corrosion while offering more strength than other metal hip replacements. Unfortunately, the alloy also came with a number of risks, such as releasing small particles of metal into the body when the neck and stem rub together. These particles can cause pain, inflammation, and blood poisoning (metallosis) that can cause blindness and neurological problems later in life.
- Fast approval process. Many lawsuits have blamed the FDA’s fast approval process for the widespread failure of metal-on-metal hip implants. Stryker’s recalled Rejuvenate and ABG II models were both approved through the FDA’s 510(k) Premarket Notification program, which allows faster clearance for products that are similar to FDA-approved ones. The Stryker devices were approved because they were comparable to other metal hips cleared by the FDA, even though the existing devices were suspected of carrying risks to patients.
- Inadequate testing. While this process may allow patients faster access to new devices, it also requires that the patients act as test subjects. The 510(k) program allows companies to bypass premarket testing, allowing them to be implanted in patients before the potential side effects are known. The companies are only required to conduct post-market research—in Stryker’s case, the research that ultimately led to the recall.
What Should Patients Do If They Were Implanted with Stryker Devices?
Stryker has advised patients who received a faulty Rejuvenate or ABG II hip implant to undergo a complete medical evaluation if they are experiencing any pain or discomfort in the hip joint. These checkups may include imaging tests (such as X-rays or MRIs) as well as blood tests to check for evidence of high levels of toxic metals in the body. Patients who are suffering from device failure, adverse tissue reactions, or other complications will likely need to undergo revision surgery to remove the device and replace the implant with a ceramic or non-reactive device.
If you are not sure which device you received or have already undergone revision surgery, the McGartland Law Firm can help you. We can examine your surgery records to determine which device was implanted and calculate your full personal and financial losses due to a faulty Stryker device. Contact us today to discuss your case with an attorney. We offer a free case evaluation and we do not collect any legal fees unless we are able to secure you a settlement.