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The U.S. Food and Drug Administration (FDA) recently issued a critical safety communication concerning the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System), a commonly used hip replacement device. The Zimmer CPT is a Collarless Polished Tapered femoral stem made of a cobalt-chromium molybdenum alloy. The implant is a cemented stem.
Recent research has shown that this device carries an increased risk of thigh bone fractures following surgery, known as postoperative periprosthetic femoral fractures. These fractures can be extremely painful and often necessitate additional surgical intervention, posing significant risks for affected patients.
Zimmer Biomet issued a safety notice of the CPT Hip System in July 2024, aiming to update the instructions for use due to the elevated risk of fractures. The Zimmer Urgent Medical Device Field Safety Notice disclosed its plan to update to their IFU to disclose the risk of periprosthetic femur fracture – a rate of 1.4% periprosthetic fractures in UK data, which is more than twice the risk of periprosthetic fractures compared to stainless steel alternatives. (Link to notice from Jason)
However, the FDA has raised concerns about the continued implantation of this device, given the heightened risk compared to similar hip replacement devices. The manufacturer plans to phase out the sale of the device by December 2024, but the risks remain for patients who have already received this implant or who may receive it in the coming months.
On 9/17/24, the FDA issued a Safety Communication regarding risk of fracture.
The CPT Hip System is designed to replace a damaged or worn-out hip joint, helping patients regain mobility and reduce pain. However, recent data suggest that this particular device has a higher likelihood of causing postoperative thigh bone fractures than other hip replacement devices. These fractures can occur around the femoral stem, the part of the implant that fits into the thigh bone, and they often require extensive medical treatment, including revision surgery to repair the damage.
The risks are not insignificant. According to research cited by the FDA, patients with the CPT Hip System have an estimated 1.4% chance of experiencing a postoperative femoral fracture. While this percentage may seem small, it is notably higher than the fracture rates associated with other similar hip replacement devices, which range from approximately 0.6% to 1%. For patients who undergo hip replacement surgery expecting relief and improved quality of life, the possibility of facing a severe fracture requiring additional surgery is a troubling outcome.
Patients with the CPT Hip System may initially experience symptoms such as pain, swelling, or difficulty walking, signaling the onset of a potential fracture. For those who have already undergone hip replacement surgery with this device, it is essential to consult with a healthcare provider if any unexpected symptoms arise. While the FDA does not recommend removing a well-functioning CPT Hip System that is not causing issues, vigilance is crucial to detect problems early.
The implications of these fractures go beyond physical pain. Revision surgery to repair or replace a fractured femoral stem is more complex and risky than the original hip replacement procedure, often involving longer recovery times, additional medical expenses, and increased complications. For many patients, the emotional and financial impact of these injuries can be just as overwhelming as the physical harm.
The harm caused by the defective Zimmer Biomet CPT Hip System can be devastating. Postoperative femoral fractures often lead to severe pain, loss of mobility, and the need for additional surgeries, which carry their own risks of infection, blood clots, and prolonged recovery. For many patients, the trauma of facing another surgery, coupled with the physical limitations imposed by the fracture, can result in a significant decline in their overall quality of life.
These fractures can also lead to long-term disability, preventing patients from returning to work or engaging in activities they once enjoyed. The psychological impact of losing independence, combined with the financial burden of ongoing medical treatments, can be overwhelming for both patients and their families. In some cases, patients may face months or even years of rehabilitation to regain their strength and mobility, if full recovery is even possible.
Given the severity of these injuries and the long-term consequences, it’s crucial for affected patients to explore their legal options. The law allows those harmed by defective medical devices to seek compensation for their injuries, medical expenses, lost wages, pain and suffering, and other damages.
If you or a loved one required revision surgery or suffered complications after implantation of a Zimmer Biomet CPT Hip System, you may have grounds to file a product liability lawsuit. These lawsuits aim to hold manufacturers accountable for producing and selling defective products that cause harm to consumers. In the case of the CPT Hip System, the claims could involve arguments that Zimmer Biomet failed to adequately warn patients and healthcare providers about the risks or that the device was defectively designed or manufactured.
The process of pursuing a product liability claim begins with consulting an attorney experienced in handling defective medical device cases. An attorney will evaluate your situation, gather evidence such as medical records, surgical reports, and the device’s recall information, and determine the best legal strategy for your case. This evidence is crucial in proving that the CPT Hip System was responsible for your injuries and that Zimmer Biomet should be held liable for the harm caused.
Once your lawsuit is filed, the legal process involves several stages, including discovery, where both parties exchange information, and pre-trial negotiations. Many product liability cases are settled before going to trial, but if a fair settlement cannot be reached, your attorney will be prepared to present your case in court.
Having an attorney is vital in these cases, as product liability lawsuits can be complex and challenging. Manufacturers of medical devices often have significant resources and legal teams dedicated to defending against claims. An experienced attorney will handle the legal complexities, negotiate with the opposing side, and advocate for your right to receive fair compensation.
Victims of defective hip implants may be entitled to various forms of compensation. These damages can include:
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