Zimmer Biomet pulled the CPT Hip System off the market after it was linked to a doubled risk of thigh-bone fractures. A broken leg with a hip replacement is extremely painful and requires surgery, often with poor outcomes.
Need a Texas CPT Hip System Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with a thigh-bone fracture after hip replacement surgery with the Zimmer Biomet CPT Hip System, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
FDA Warning for CPT Hip System Thigh-Bone Fractures
In September 2024, the FDA issued a Safety Communication after a study linked the CPT Hip System to an increased risk of thigh-bone fractures (also called “femur fractures”).
The warning specifically involves the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper, which is the “stem” part of a hip replacement that goes in the top of the patient’s thigh-bone (femur). It connects to the metal “ball” part of the hip replacement that goes in the hip socket in the patient’s pelvis.
What Is The Risk?
Unfortunately, poor outcomes are very common after surgery for thigh-bone fractures after hip replacements. The long-term risks include:
- Hip pain
- Trouble walking
- One leg is shorter than the other
- Less flexibility
- Dislocation of the hip joint
- Lack of fixation of the new stem in the femur bone
- Nerve damage
- Blood vessel damage
- Infections and other surgical risks
- Higher risk of falls
- Poor healing
- Increased risk of death
What Happened?
The CPT Hip System Femoral Stem is a polished taper-slip (PTS)-style stem. It is a metal implant that is made of a chromium-cobalt alloy.
Unfortunately, studies have linked the CPT Hip System to a significantly higher risk of femur fractures than other PTS stems that had a similar design, but made of a different material, such as stainless-steel.
2X Higher Risk of Femur Fractures From CPT Hip System
The risk of thigh-bone fractures was estimated at 1.4% of patients, according to a study in the United Kingdom. This risk was more than double the risk of thigh-bone fractures with other PTS stems.
Zimmer Biomet Stops Selling CPT Hip System
In response to the increased risk, Zimmer Biomet sent out an Urgent Medical Device Safety Notice on July 1, 2024, announcing that it would phase out sales of the CPT Hip System by December 2024.
What Is The Problem?
Femur fractures are extremely painful and will usually have patients headed straight to the emergency room for surgery. These fractures are very serious.
The surgery is technically challenging and often has poor long-term outcomes, especially if the bones surrounding the hip implant break apart into multiple fragments, or the metal stem has come loose.
Many patients need to undergo a complex surgery to repair the femur, and potentially re-implant a new metal hip stem if the original one is loose due to broken bones surrounding the implant.
Thigh-Bone Fractures Can Happen At Any Time
Thigh-bone fractures around a hip implant can happen at any time, even after years of living with a well-functioning hip implant. They usually occur after a fall. The risk is highest for older patients, women, patients with thinning bones due to osteoporosis, previous hip surgeries, or other health issues that can cause an elderly person to fall (such as poor eyesight).
Long-Term Increased Risk of Death
Studies have shown an increased risk of death after surgery to repair a thigh-bone fracture around a hip replacement. Many patients never regain full function of their hip or their previous ability to walk. The recovery period is very long and quality of life may never be the same. Patients must be careful not to fall again. The healing process is often slow, especially for older patients with underlying health issues.
Symptoms of Thigh-Bone Fractures
The most common symptoms of thigh-bone fractures around hip replacements include:
- Hip pain (usually very severe)
- Pain in the upper-thigh area
- Swelling or bruising of the hip or thigh
- Unable to walk
- Inability to put weight on the injured leg
- Injured leg looks shorter or deformed
What Is The Thigh-Bone?
The thigh-bone is also called the femur. It is the longest, strongest, and heaviest bone in the body because it must support the entire body-weight of a person while standing up, walking, and running.
What Do Doctors Call Broken Bones Around Hip Implants?
Broken bones around a hip replacement are also called Periprosthetic Fractures. They are usually caused by a fall, but also sometimes high-energy impacts like car accidents. In the medical community, the technical term for this injury is a Postoperative Periprosthetic Femoral Fracture (PFF).
What Is The Femoral Stem?
During a hip replacement, a surgeon puts a long metal shaft called the “femoral stem” into the center of the upper-part of the femur, along with bone cement to help it stay in place. The top of the metal stem is attached to other metal components that fit into the hip socket. There are many styles of femoral stems, but the CPT Hip System is a polished taper-slip (PTS)-style stem made of chromium-cobalt.
What Happens If You Break Your Femur After Hip Replacement?
Femur fractures after hip replacements are extremely painful and require surgery. This surgery is complex. If the implant is loose, it will be removed and replaced. The broken femur must also be repaired using plates, screws, or wires to secure the bone around the implant. Even in the best-case scenarios, many patients suffer poor outcomes like chronic pain or mobility challenges.
Why Is This Surgery So Challenging?
Another factor that adds complexity is the use of bone cement. Surgeons commonly use bone cement to help the CPT Hip System stay fixed in place inside the middle of the thigh-bone. When the thigh-bone breaks apart, the bone cement must be removed along with the old metal stem that is loose.
There may be very little original thigh-bone left after removing the old metal stem, broken bones, and bone cement, which is a significant challenge because the surgeon has nowhere to put a new stem. The surgeon will have reconstruct the femur by transplanting bone grafts from a deceased donor (cadaver).
Internal Fixation Surgery For Thigh-Bone Fracture
If the metal stem is still firmly fixed after a thigh-bone fracture, surgeons may try to repair the bone using screws, cables, metal plates, or transplanting a bone graft. This is called “internal fixation.”
How Long Does It Take To Recover?
The recovery process following surgery for a thigh-bone fracture will usually take several months, including several weeks in a rehabilitation center or skilled nursing facility. Tragically, many patients never regain full function of their hips. They may always need a walker or a leg brace.
Why Is CPT Hip System Still Being Used?
The FDA said it “has concerns about the CPT Hip System continuing to be implanted in new patients, given recent research that found a higher risk of thigh bone fracture…” The FDA urged surgeons to “consider using an alternative prosthesis where possible.”
The CPT Hip System remains on the market until the end of 2024, but safety officials in the U.K. have also strongly warned “against its use for elective surgery except in exceptional circumstances. Surgeons should consider using an alternative prosthesis.”
Hip Implant Lawsuits Are Being Filed Nationwide
Over the past few years, Zimmer Biomet and many other hip implant manufacturers have been hit with thousands of lawsuits involving people who were injured by different types of hip replacements.
These lawsuits have been filed by people who were injured by metal-on-metal hip replacements and other implants that were pulled off the market after studies showed unacceptably high rates of failure.
Lawsuits Claim Hip Implants Were Defective, Unsafe, Dangerous
Most of these lawsuits accused manufacturers of failing to adequately test a defective hip implant before it was advertised as “safe.” Patients thought they were getting a safer type of implant, but in reality, they were the first ones to be injured by a new medical device with unexpected problems.
Can I Join A Class Action Lawsuit?
Instead of a class action, hip implant lawsuits are commonly filed as individual cases by people with their own attorney. If a lot of lawsuits are filed by other people who were injured by the same implant, judges may decide to establish a Multi-District Litigation (MDL).
MDL vs. Class Actions for CPT Hip System Lawsuits
The MDL process has similarities to a class action because a lot of hip implant lawsuits can be coordinated into one court, under one judge. This improves efficiency, cost-effectiveness, and helps lawyers coordinate the discovery process when they are gathering evidence.
If a lawsuit in the MDL goes to trial, the outcome of this trial can be used to help resolve a lot of other lawsuits involving similar facts, circumstances, or injuries.
How Much Is My Lawsuit Worth?
There is no way to know the outcome of any lawsuit. Hip implant lawsuits could end in a jury verdict, multi-million dollar settlement, or dismissal of the case without any financial award for the plaintiffs. In general, your lawyer will try to seek financial compensation for your pain and suffering, medical bills, long-term injuries, decreased quality of life, wrongful death of your family member, and more.
Advantages of Hip Implant Lawsuit Settlements
The MDL could end in a massive multi-billion dollar settlement, which is often advantageous for people who were injured. Medical device companies who choose a settlement can also avoid a long drawn-out litigation with expensive jury trials, and negative press surrounding a dangerous medical device.
Need a CPT Hip System Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.