Stryker Medical Device Defect Attorneys
Stryker Rejuvenate & ABG II Modular Hip Stem Devices
Stryker Orthopaedics, a developer of various medical devices, has recalled and stopped global distribution of its Rejuvenate and ABG II modular hip stems as the result of adverse effects and higher than acceptable failure rates. The defective medical device attorneys at Robinson Calcagnie, Inc. are investigating claims of patients who have suffered or are currently suffering from swelling and/or pain of the hip area caused by adverse local tissue reaction (ALTR) from the modular hip stem, or who have undergone revision surgery to correct problems related to the device.
The recall was initiated in June 2012 for the Rejuvenate device and July 2012 for the AGB II device. At that time, the U.S. Food and Drug Administration (FDA) had already received more than 60 adverse event reports. As of April 2013, at least 81 lawsuits against the company claiming that the hip devices are defective have been consolidated in New Jersey, with hundreds more expected.
During post-market surveillance of the Rejuvenate and ABG II modular-neck hip stems, it was determined that the modular stems carry a high risk of fretting and corrosion. This may cause ALTR in addition to other potential medical complications elsewhere in the body. The data concerning these effects was considered predictive as a trend and led to the recall.
Adverse Effects of Stryker Implant Failure
Normal use of the hip replacement devices can lead to a number of significant adverse effects, eventually requiring revision surgeries to remove the failing device and repair the tissue damage it may have caused users of the product. Such circumstances can lead to substantial physical, emotional and financial trauma. Some of the common adverse effects caused by the Rejuvenate and ABG II modular hip stems include:
- Bone and tissue damage
- Necrosis of tissue
- Inflammation and swelling
- Mobility problems
Many of the patients who had received the Stryker modular hip stems may have experienced one, if not all, of the above reactions as the result of hip stem loosening and/or failure. Some may have already undergone revision surgery.
Stryker was able to market these hip implants without providing pre-market clinical safety data, through the controversial 510(k) clearance process, which allows manufacturers to forgo pre-market clinical testing if they can establish that their product is similar to a product already on the market.
Understanding Your Pain, Suffering, and Legal Rights
If you have received a hip replacement since 2008 and are experiencing pain, swelling, or other adverse complications, or had to undergo revision surgery, it is important that you determine whether the device used is either of the above recalled hip stems.
Medical device manufacturers are responsible for the safety of their products. If you have suffered adverse effects and/or revision surgeries as the result of a defective Rejuvenate or ABG II modular hip stem, we can help. Please contact our lawyers for a free evaluation of your potential case.