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.

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.

CONTACT KBA, OR LEARN MORE ABOUT THE ZIMMER BIOMET CPT HIP SYSTEM BELOW

If you or a loved one has been affected by complications from the Zimmer Biomet CPT Hip System or similar devices, 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.

FDA Issues Safety Alert on Zimmer Biomet CPT Hip System

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding the Zimmer Biomet CPT Hip System, highlighting an increased risk of postoperative thigh bone fractures associated with the device.

Understanding the Zimmer Biomet CPT Hip System

The CPT Hip System Femoral Stem 12/14 Neck Taper is a polished taper-slip (PTS) style stem made from cobalt chromium alloy, used in hip replacement surgeries to mimic the natural hip joint’s function.

Increased Risk of Thigh Bone Fractures

Recent research found in the FDA notice indicates that patients implanted with the CPT Hip System face a higher risk of postoperative periprosthetic femoral fractures (PFF) compared to similar devices. Notably:

• Fracture Rate: Approximately 1.4% for the CPT Hip System, higher than the 0.6% to 1% observed in similar PTS hip stems.
• Consequences: These fractures often necessitate additional surgeries, such as internal fixation or implant replacement, leading to increased patient morbidity.

FDA Recommendations for Patients and Caregivers

If you have received a Zimmer Biomet CPT Hip System implant, consider the following:

• Consult Your Healthcare Provider: Discuss the benefits and risks of all available hip replacement devices.
• Monitor for Symptoms: Be vigilant for unexpected pain or difficulty walking, and seek medical advice promptly if these occur.
• Routine Follow-Ups: Continue with your existing follow-up schedule if you are asymptomatic; the FDA does not recommend removal of a well-functioning CPT Hip System.

FDA Recommendations for Healthcare Providers

Per FDA’s notice, Healthcare professionals should:

• Discuss Risks with Patients: Inform patients about the increased risk of postoperative femoral fractures associated with the CPT Hip System.
• Consider Alternative Implants: Evaluate the use of alternative prostheses where possible.
• Report Adverse Events: Promptly report any complications related to the CPT Hip System to the FDA.

Zimmer Biomet’s Response and Product Phase-Out

In response to these concerns, Zimmer Biomet initiated a voluntary medical device field action correction on July 2, 2024, updating the instructions for use to include the risk of PFF. The company plans to phase out the CPT Hip System Femoral Stem in the U.S. by the end of October 2024, transitioning surgeons to alternative brands.

Legal Implications and Patient Rights

Patients who have suffered complications due to the CPT Hip System may be entitled to compensation. Potential claims include:

• Product Liability: Alleging defective design and failure to warn about known risks.
• Negligence: Asserting that Zimmer Biomet failed to ensure the device’s safety.

Why Choose KBA Attorneys?

At KBA Attorneys, we specialize in defective medical device litigation and are committed to holding manufacturers accountable. Our experienced legal team offers:

• Expertise in Medical Device Cases: A proven track record in handling complex medical device lawsuits.
• Personalized Legal Strategies: Tailored approaches to meet each client’s unique needs.
• No Upfront Fees: We operate on a contingency fee basis, meaning you pay nothing unless we recovered money on your case, then we get our fees and costs back. See our fee agreement for details.

Contact Us for a Free Consultation before Its Too Late

If you or a loved one has experienced complications from a Zimmer Biomet CPT Hip System, contact us today for a free, no-obligation consultation to discuss your legal options.

Call us at 855-KBA-LAWS (522-5297); Email us at Infor@KBAattorneys.com

How Would I know if I have a Zimmer Biomet Hip Claim?

​If you had hip replacement surgery, find out if it involved the Zimmer Biomet CPT Hip System. You can obtain your medical records, or retain us to do so. Next, see if the Zimmer Biomet hip caused your complications. 

Identifying Potential Hip Implant Issues

Patients with the Zimmer Biomet CPT Hip System should monitor for the following signs and symptoms, which could indicate implant failure:​

• Unexpected Pain: New or worsening pain in the hip or thigh area.​

• Difficulty Walking: Challenges with mobility, limping, or instability while standing or walking.​

• Swelling or Inflammation: Unusual swelling around the hip joint.

• Audible Sounds: Clicking or grinding noises emanating from the hip area during movement.

Experiencing any of these symptoms warrants prompt consultation with a healthcare provider to assess the integrity of your hip implant.​

Legal Eligibility for a Claim

You may be eligible to file a lawsuit if:

• You received a Zimmer Biomet CPT Hip System implant.​

• You suffered a postoperative periprosthetic femoral fracture.

• You underwent or have been advised to undergo revision surgery to address implant-related complications.​

Legal actions aim to secure compensation for medical expenses, lost wages, pain and suffering, and other related damages

Next Steps if You Had a Zimmer Biomet Hip

1. Consult Your Healthcare Provider: Seek medical evaluation for any concerning symptoms to document your condition.​

2. Gather Medical Records: Compile documentation of your hip replacement surgery, follow-up visits, and any related medical interventions.​

3. Seek Legal Counsel: Engage with an attorney experienced in medical device litigation to assess your case.​

At KBA Attorneys, we represent individuals defective medical devices injure, including the Zimmer Biomet CPT Hip System. Our team is dedicated to guiding you through the legal process to ensure you receive the compensation you deserve. Contact us for a comprehensive evaluation of your case. 855-KBA-LAWS (522-5297). 

​Note: Legal claims are subject to statutes of limitations, which vary by state. Prompt action is essential to preserve your rights.