New Jersey product liability attorneys help clients hurt by dangerous medical devices
Medical device manufacturer Stryker Corp. has received an unprecedented number of complaints regarding its Stryker Accolade hip replacement system. The problem stems from the femoral head that is used with the hip replacement product, including the Accolade TMZF and Accolade 2 stems. The underlying problem is based on a taper lock failure of the stem.
Stryker uses TMZF for its Accolade product, which includes a mix of titanium, molybdenum, iron and zirconium. The Accolade systems use several neck and stem components that are intended to be interchangeable to help surgeons with custom-fit designs rather than the traditional design that uses only one larger piece. Stryker has received reports from other products regarding corrosion and the release of toxic metals into their patients which may also be problems associated with the latest recall.
Patients with similar devices made over 60 reports to the FDA regarding metal toxicity that required revision surgery. The company has previously advised patients who had hip implant systems of this type to have medical tests taken such as MRIs, blood tests, X-rays and other evaluative processes. Medical professionals recommend implementing revision surgery to substitute a ceramic replacement for the modular pieces. However, such surgeries run the risk of femur fractures during such surgeries.
Potential problems that can result from the hip replacement system include:
- Disassociation of femoral head from the hip stem
- Insufficient tension in the soft tissue
- Loss of strength of the bone
- Bone dissolution
- Loss of implant
- Fractured hip stem trunnion
- Excessive wear
- Premature death of the tissue
Due to the possibility of metal components rubbing against each other, one serious concern related to hip replacement products includes the likelihood that metal debris may be deposited into a person’s tissues, bones or bloodstream. This condition is referred to as metallosis, which occurs when there is metal toxicity due to grinding metal components.
Stryker Orthopaedics has finally notified surgeons that they decided to voluntarily recall certain lots and sizes of their LFIT ANATOMIC COCR V40 FEMORAL HEADS because of serious health risks to patients. A number of Lot and Item Numbers are included in the identified affected products, totaling hundreds of such Lot and Item Numbers. The affected units run from size 36 through 44 and include the cobalt/chrome metal heads. The affected femoral heads were manufactured prior to 2011.
The company that is responsible for marketing more than 57,000 products across the globe has not publicly stated whether the reason for the voluntary recall is due to a manufacturing defect that was discovered or if it is due to a design problem. Unfortunately, many Americans were implanted with this hip replacement system, and many have experienced debilitating pain or forced to undergo a second revision surgery because of design flaws in this defective medical device.
Physicians began notifying patients of this recall by letter in late September of 2016. If you received a notice of recall from your Orthopedic Surgeon, it is very important that you consult with an experienced attorney right away to ensure your legal rights are protected.
The medical device manufacturer has been plagued with a number of other recalls in recent years, including recalls for the Accolade TMZF Plus Hip Stem in 2009, 2011 and 2013 and the Rejuvenate and ABG II Modular-Neck Hip Stems that were recalled in 2012. These previous recalls resulted in the company issuing Urgent Safety Alerts to surgeons and hospital risk managers. Health Canada recalled the femoral head in September 2015 and August 2016 due to the high number of complaints regarding the taper lock failure.
It is important for patients who have been injured by a defective medical product to contact a skilled product liability lawyer when they become aware of problems associated with them. There is a limited amount of time to bring a claim and seek compensation for injuries stemming from injuries related to defective products.
At Lomurro Law, our New Jersey product liability attorneys have the knowledge and experience you need on your side. We have a long history of success handling large-scale injury cases which require extensive resources and legal savvy to obtain a favorable outcome. If you or someone you love has been injured due to a faulty Stryker Accolade hip, we can help. Contact us toll-free at 732-482-9285 or online today.