The U.S. Food and Drug Administration (FDA) has issued a critical safety alert regarding the Zimmer hip implant, CPT Hip System Femoral Stem 12/14 Neck Taper. This hip replacement medical device increases the risk of thigh bone fractures after surgery.
This announcement is particularly significant for patients with this hip replacement implant, their caregivers, healthcare providers, and medical facilities.
If you had hip joint replacement surgery with a recalled Zimmer hip implant, you may experience hip implant failure.
On September 18, 2024, Zimmer Biomet contacted U.S. surgeons and sent a letter with FDA recommendations. The letter included a simple guide for talking to patients and details about stopping the CPT Hip System Femoral Stem in the United States.
Contact your medical care provider if you or a loved one are experiencing hip pain after hip replacement surgery. If you have experienced symptoms of hip replacement failure, contact The Yost Legal Group for guidance.
FDA Safety Alert Issued September 17, 2024
Attention to patients: The U.S. Food and Drug Administration (FDA) has warned about a higher risk of thigh bone fractures after surgery when using the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper.
The FDA’s safety alert underscores alarming findings about the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper.
Recent reports and studies indicate that patients with this specific implant have a higher risk of thigh bone fractures. This risk occurs after surgery.
These fractures can happen because of stress at the neck taper junction of the femoral stem. This design flaw weakens the implant over time.
Such complications can lead to severe pain and decreased mobility and require additional surgeries to correct.
These fractures can necessitate surgical intervention, highlighting the urgency of the issue. You may require revision surgery to remove and replace the defective hip implant.
Recommendations for Patients and Caregivers
In response to these findings, Zimmer Biomet has taken immediate action by issuing a follow-up letter to all U.S. surgeons who have utilized this product in their practice.
This letter includes clear FDA recommendations to reduce risks for current patients and guidelines for informing those affected by possible complications.
The letter also offers a plain-language guide designed for surgeons to effectively communicate these risks with their patients, ensuring transparency and fostering trust during this difficult time.
– Talk to your orthopedic surgeon about the pros and cons of each hip replacement option. This will help you make an informed decision that best suits your needs.
– Pay close attention to care after your surgical procedure to reduce the risk of thigh bone fractures after using the CPT Hip System.
– Talk to your doctor if you’ve had a CPT Hip System implant and are experiencing unexpected pain or trouble walking.
– Contact The Yost Legal Group to learn about your legal rights to file a hip replacement lawsuit against Zimmer.
Device Description of Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper
The CPT Hip System Femoral Stem is a medical implant used for hip replacements. It is crafted from a cobalt-chromium alloy and features a polished taper slip (PTS) style stem.
A report from the Medicines and Healthcare products Regulatory Agency (MHRA) was released on September 4, 2024. It analyzed the most commonly used PTS Hip Stems in the UK. The report found that the CPT Hip System has about a 1.4% chance of causing a fracture around the thigh bone.
Similar designs have fracture rates ranging from about 0.6% to 1%.
If your artificial hip is causing complications, your metal hip implant may be failing. Hip replacement recovery time differs for everyone based on age, health, and many more reasons.
What are the signs of a failed Zimmer hip implant?
Persistent Pain and Discomfort in your hip implant
One of the most common signs that something may be wrong with your Zimmer Biomet hip implant is ongoing pain in the hip.
Some discomfort is expected during recovery after hip surgery. However, if the pain continues or gets worse long after rehab, it is a concern.
This could manifest as sharp, stabbing pains or a constant dull ache that doesn’t go away even with rest. Such pain may indicate issues like loosening of the implant, infections, or even fractures around the implant site.
Limited Mobility and Stiffness in your hip area
Another significant symptom to watch out for is reduced mobility and stiffness in the hip joint. A successful hip replacement should improve your range of motion.
A successful hip replacement should help you move better. If you have trouble with daily activities like walking, bending, or climbing stairs, it could mean a problem with your implant.
The surrounding muscles and tissues might also feel unusually stiff or swollen.
Audible Clicking Sounds from your hip replacement
Hearing strange sounds like clicking or popping when you move your hip can be concerning. These noises may indicate a problem with your Zimmer Biomet implant.
These noises often arise due to parts of the implant not fitting together correctly or becoming misaligned over time.
It’s important to seek medical advice if you detect any abnormal sounds coming from your hip joint because they can precede more severe complications.
Inflammation and Swelling around the hip implant area
Persistent inflammation and swelling around the affected hip are other indicators that something might be amiss with your implant.
Normal swelling after surgery should go down slowly. However, if you have ongoing swelling with warmth around the joint or redness down your leg, it may indicate an infection.
It could also be a bad reaction to metal debris from wear and tear on your Zimmer Biomet device.
A feeling of Instability and Dislocation of your hip replacement implant
If you feel instability in your hip joint, it may give way under pressure. This is a warning sign of possible failure in your Zimmer Biomet hip replacement.
In severe cases, patients might experience dislocation where the ball slips out of its socket entirely – an urgent medical emergency requiring immediate attention.
This instability can result from improper positioning during surgery, wearing out components over time leading to loosening, or weakened surrounding musculature unable to support proper alignment.
Unique Device Identifier (UDI)
The FDA created a unique identification system to track medical devices from their production to when they reach patients in the United States. To learn more about this system, visit the Unique Device Identification System (UDI System).
What are your legal rights to file a hip replacement lawsuit?
The Yost Legal Group is a top-rated personal injury law firm focusing on product liability lawsuits, such as defective hip replacement implants. There have been many Zimmer Biomet hip replacement recalls.
Our team has experience with defective medical device cases like yours. Our product liability law firm is ready to handle complex legal issues. We can file a hip implant lawsuit for you to recover damages like pain and suffering.
We understand that you’ve already endured significant physical pain and emotional distress due to your initial hip replacement surgery. It is compounded by learning about potential defects in your implanted hip replacement device.
If you are experiencing pain or bone loss due to your Zimmerman Biomet hip replacement implant, call us for a free consultation.
Contact The Yost Legal Group for help.
If you are facing another round of corrective surgery, you don’t have to face these challenges alone.
Contact The Yost Legal Group at 800-967-8529 for a free consultation to learn about your rights. You can also fill out the form on our website and we will contact you shortly.
You’ll receive guidance on how best to proceed legally against manufacturers who failed you through negligence or oversight. If you need a revision hip replacement surgery because of complications, including side effects and long-term pain, call us.
We will file a product liability claim against the medical device manufacturer on your behalf.
