FDA Issues Alert on Zimmer Biomet CPT Hip System and Increased Fracture Risk

The FDA has issued a warning about the increased risk of thigh bone fractures following surgery with the Zimmer Biomet CPT Hip System. This specific hip replacement device has raised concerns due to a higher rate of postoperative periprosthetic femoral fractures, a serious complication that can require additional surgery to address. As a result, the manufacturer, Zimmer Biomet, initiated a voluntary recall and announced plans to phase out the CPT Hip System by the end of 2024.

Zimmer Biomet Recalls CPT Hip System

On July 2, 2024, Zimmer Biomet voluntarily recalled the CPT Hip System to update its instructions for use. The recall was driven by concerns over the higher-than-expected risk of thigh bone fractures associated with the device. The company also confirmed its intention to halt sales of the CPT Hip System by December 2024.

Despite this recall, the FDA remains concerned about the device’s use. Research shows the CPT Hip System has a significantly higher risk of fractures compared to other hip replacement devices. The FDA is actively working with Zimmer Biomet to ensure patients and healthcare providers understand these risks and to develop strategies to reduce potential harm.

Increased Risk of Thigh Bone Fractures

Recent research has highlighted the elevated risk of postoperative thigh bone fractures with the CPT Hip System. These fractures, also known as periprosthetic femoral fractures, occur around the femoral stem of the hip implant and can be debilitating. Compared to similar hip devices, the CPT Hip System has shown a fracture rate of approximately 1.4%. Other similar designs have a fracture rate between 0.6% and 1%.

This difference in fracture rates has prompted the FDA and other international regulatory agencies to evaluate the safety of the CPT Hip System closely. The likelihood of needing additional surgery if a fracture occurs has raised significant concerns for patients already implanted with the device.

Zimmer CPT Hip Recommendations for Patients and Caregivers

The FDA has issued specific guidance for patients and caregivers affected by the CPT Hip System recall. If you have had the CPT Hip System implanted, be aware of the increased risk of thigh bone fractures. Symptoms to watch for include unexpected pain and difficulty walking. It is essential to consult your healthcare provider if you experience any of these symptoms.

However, if you do not have symptoms and your implant is functioning well, the FDA does not recommend removal. The best course of action is to continue with your regular follow-up appointments and to stay informed about any updates related to the CPT Hip System.

Patients are also encouraged to report any problems they experience with their CPT Hip System to the FDA. This feedback helps regulatory agencies track device performance and take further action if necessary.

Zimmer CPT Hip Recommendations for Healthcare Providers

Healthcare providers also play a critical role in mitigating the risks associated with the CPT Hip System. The FDA recommends that providers review the latest guidance with their patients. Especially if the patient already has the device implanted. In cases where a hip replacement is a requirement, doctors should consider using an alternative device if possible.

If no alternative hip replacement options are available, healthcare providers must inform patients of the higher risk of fractures associated with the CPT Hip System. Full transparency allows patients to make informed decisions about their health.

Additionally, healthcare providers are urged to report any problems their patients experience with the CPT Hip System to the FDA.

Hip Replacement Complications and the Zimmer Biomet Recall

The Zimmer Biomet CPT Hip System recall is not the first time hip replacement devices have faced scrutiny. In recent years, several other devices have been recalled for similar issues. This is including metal-on-metal hip implants and Exactech hip replacement systems. Like the CPT Hip System, these devices have been associated with serious complications. Some include fractures, implant failure, and the need for revision surgeries.

Hip replacement surgery is a significant procedure. While it can offer relief from chronic pain and mobility issues, it also carries risks. When medical devices like the CPT Hip System or Exactech products fail, they can lead to prolonged recovery times, additional surgeries, and lasting health impacts.

Exactech and Hip Injury Risks

In addition to the Zimmer Biomet recall, Exactech has faced its own set of challenges regarding hip implant safety. In recent years, Exactech recalled several hip and knee replacement devices due to premature wear of the polyethylene liners. This issue led to implant failure, resulting in pain, loss of mobility, and the need for revision surgery. Patients who received these faulty devices have suffered from similar complications to those associated with the CPT Hip System.

The Exactech recall serves as a reminder that patients should always stay informed about the potential risks associated with their medical implants. Whether it’s the Zimmer Biomet CPT Hip System or another brand, patients should be aware of the warning signs of implant failure and seek medical advice if they experience any issues.

Taking Action for Your Health

The FDA continues to monitor the performance of the Zimmer Biomet CPT Hip System and is collaborating with Zimmer Biomet to ensure patient safety. As more data becomes available, the FDA will provide updates on any further actions or changes regarding the device.

If you or a loved one have been impacted by complications from a hip replacement, including the Zimmer Biomet CPT Hip System or Exactech products, it’s essential to stay informed and take action. Consult your healthcare provider, report any issues to the FDA, and explore your legal options to hold manufacturers accountable for defective devices.

Patients have the right to safe, reliable medical implants, and manufacturers must ensure their products meet safety standards. Stay proactive, informed, and vigilant to protect your health.

If you or a loved one has been affected by complications from the Zimmer Biomet CPT Hip System or similar devices like Exactech, KBA Attorneys can help. Our team is actively investigating claims related to defective hip implants, including those that cause fractures, implant failure, or require revision surgery. We are committed to helping you seek the compensation you deserve for pain, suffering, and medical costs. Contact us today for a free consultation to explore your legal options.