Defective Hip Implants
People with a severely damaged hip joint can be mobile and active again with the Rejuvenate Modular Hip Neck and Stem or the ABG II Modular Neck and Stem from Stryker Corp. or with the DePuy ASR XL Acetabular metal-on-metal hip replacement from Johnson & Johnson. Being the first orthopedic company in the U.S., DePuy Orthopaedics has become a trusted name, even maintaining leadership in the hip replacement business for more than 4 decades. Though, its product entered the U.S. market only in 2005, the year it was cleared by the US Food and Drug Administration (FDA) for distribution, it still came out four years ahead of Stryker Corp.’s prosthetic implants, which the FDA approved in 2009 to treat people with a fractured hip.
Damaged hip joints that cause persistent pain and which made everyday activities so much harder to accomplish need to be replaced with an artificial joint, also known as prosthesis. Prosthetics are made either from metal alloy or ceramic. These have been used in hip replacement surgery, which has been a medical practice since the 1960s. Hip replacement surgery is intended to improve a person’s quality of life by relieving him/her of the pain due to damaged hip, as well as improving the function of his/her hip and ability to move around.
The Rejuvenate Modular Neck Stem Hip served as a substantial equivalent of the already available Wright Medical Profemur Hip Implant Replacement, thus, the FDA accepted it under its 510(k) process and so, approved it without the thorough pre-market testing and research requirement mandated of new products.
The major difference,and advantage these Stryker products had was their capability to minimize bone stress and provide greater stability which were made possible by the six stems and 16 necks (of the Rejuvenate hip) and the 10 modular necks, eight left stems and eight right stems (of the ABG II system). Thus, compared to the one-piece neck and stem (known as the monoblock design) of other hip implant systems, the Rejuvenate and the ABG II gave surgeons much more flexibility in custom-fitting these prosthetic implants into patients.
With its titanium alloy blend, which is a mixture of iron, zirconium, molybdenum and titanium, Stryker was also able to claim and assure corrosion and fretting resistance, a case wherein metal particles would flake off and mix into the blood. However, these claims were proven false as post-market data showed proofs of corrosion and fretting in patients who had the device implanted in them. Aside from this the release of toxic metals, loosening of the implant and other side effects (which require corrective surgery) were linked to the device – the reason behind the many lawsuits filed against Stryker Corp.
In the case of Johnson & Johnson’s DePuy ASR XL Acetabular metal-on-metal hip replacement, about 400 complaints reached the FDA beginning in 2008, concerning required revision surgeries on patients, who received the DePuy ASR hip replacement. The problem , however, was, even if the defective device was replaced, it was very possible that it has already left dangerous, even deadly fragments inside the body. Other DePuy hip implant problems included fracture of the bone, component misalignment, loosening components, metal sensitivity, dislocation, pain, bone staining, nerve, muscle and tissue damage, increased levels of metal ion in the blood, infection, swelling and necrosis (or tissue death).
Due to complaints, DePuy Orthopaedics, Inc. issued a recall on its product on August 24, 2010, more than a year before the first lawsuit was filed against the company. However, with more than a million patients worldwide having received the DePuy hip implant, more lawsuits are expected to be filed.
For the Stryker product, Stryker Corp. voluntarily recalled its Rejuvenate in July 2012 after hundreds of lawsuits were a filed against it.
According to the law firm Habush Habush & Rottier, “Some of the signs of trouble with a defective implant include swelling, pain, and difficulty walking. Persistent symptoms can signal a loose implant, fracture of the bone around the implant, or dislocation of the implant’s ball and socket. In addition, due to poor design in some hip implants, microscopic chromium and cobalt shards can enter the blood stream due to metal on metal contact. It is possible to have elevated chromium and cobalt levels with no symptoms, so you should follow up with your physician even if you are not having symptoms.”
Patients who have been implanted with the DePuy ASR XL Acetabular Syste, the Stryker Hip Implants or the Zimmer Durom Cumay probably need to undergo medical test just to make sure they are safe from the harmful effects linked to any of the devices mentioned above. In case of possible harm, it may be wise for affected patients to get in touch with a personal injury lawyer immediately who may be able to help them understand more their legal rights and options.