Total joint replacements are some of the most common elective surgeries in the United States. By one measure, more than one millions knee and hip replacements are performed annually.
In many of those procedures, surgeons use bone cement to affix prosthetic replacement joints to the patient’s bones.Some of those patients are now coming forward with complaints that certain bone cement manufacturers may have downplayed the risks of the substance. Those risks include premature failure that force patients to undergo revision surgeries, serious soft tissue irritation and inflammation, and migration of cement residue into the patient’s bloodstream and lungs.
Showard Law Firm represents patients who have suffered complications as a result of dangerous bone cements used during joint replacement surgery. Patients may be entitled to compensation for their medical expenses, lost wages, pain and suffering, and other costs incurred as a result of exposure to certain types of bone cement.
Bone Cement Manufacturers
Surgical bone cement is made by several of the world’s largest medical device manufacturers. Bone cements vary according to their viscosity and other included components. Patients are often unaware of which manufacturer made the bone cement or what type of cement was used in their joint replacement procedure.
The products and manufacturers that have been the focus of recent legal inquiries are:
- Cobalt HV Bone Cement (Biomet/DJO Surgical)
- CMW 1 Bone Cement (DePuy)
- Simplex HV Bone Cement (Stryker/Howmedica)
- SmartSet HV Bone Cement (DePuy)
Symptoms of Bone Cement Failure
Bone cement failure may be difficult to detect given the patient’s medical history dealing with joint pain prior to replacement, pain during the aftermath of surgery, and throughout the rehabilitation process. However, patients should not overlook symptoms or dismiss signs of a new problem.
Symptoms of bone cement failure include:
- Unusual inflammation or swelling at the site of the joint replacement
- Persistent or chronic pain that does not abate after physical therapy
- Decreased range of motion or weakness in the limb that was the subject of the surgery
- Lack of balance or instability that cannot be explained by other causes
Legal Allegations in Bone Cement Complaints
Liability in medical device lawsuits is premised on product defects or known product risks that were not fully disclosed to a patient. Under this standard, a bone cement manufacturer owes patients a duty to produce products that are safe and effective when they are used properly; and to disclose all known risks associated with those products in order to help patients give their informed consent for surgery.
The allegations in at least one recent bone cement lawsuit include multiple allegations that a manufacturer failed on both of those obligations. That plaintiff who underwent a total knee replacement, experienced severe pain soon after the surgery. Tests revealed that the bone cement that had been used to secure her prosthetic knee joint had deteriorated. That deterioration required the patient to undergo a revision surgery to correct the failure.
She claimed that if she had known about the risks and potentially dangerous character of the bone cement that was used in the first surgery, she would not have consented to have the replacement in the first place.
FDA Approval as an Element of a Bone Cement Lawsuit
One critical consideration in these lawsuits is that each bone cement product must be approved for use by the Food and Drug Administration (FDA) before it can be utilized in a surgical procedure.
In some cases, the FDA allows bone cement manufacturers to gain approval for their products subject to regulation 510(k), an abbreviated approval process. If a new bone cement product is said to be substantially equivalent to another cement product that has already received FDA approval, then the new product may be fast-tracked to the marketplace. This may be true even if the products on which the new products are based have been allegedly problematic for patients in the past.
The FDA also maintains regulations that govern the processes and procedures that medical device manufacturers must follow after a product has received FDA approval, including the maintenance of records describing the failure of medical products. Bone cement manufacturers that receive reports of problems with their products are thus obligated to record that information and to remove faulty products from the marketplace. Plaintiffs in bone cement lawsuits have alleged that manufacturers have not complied with these and other obligations under applicable FDA regulations.
Potential Damages Awards in Bone Cement Lawsuits
This litigation is still in its early stages. To the extent that courts and juries conclude that bone cement manufacturers are liable for placing defective medical products into the marketplace or for failing to disclose the known risks associated with those products, damages awards will include compensation for corrective revision surgery and associated rehabilitation costs, replacement of lost wages, and payments for pain and suffering.
All plaintiff circumstances are unique to each particular patient including the type of surgery performed as well as the products utilized in that procedure. Accordingly, a patient’s potential damages award cannot be guaranteed. If a patient has suffered an injury due to a manufacturer’s faulty product, that patient should consult with an experienced attorney who can advise the patient on all of his or her options.
Bone Cement Claims Subject to Statutes of Limitation
The statute of limitations for these types of lawsuits is relatively short. Lawsuits filed after the expiration of the statute may cause your case to be dismissed. Patients are encouraged to consult with an attorney as soon as is possible after exhibiting symptoms.
Do You Qualify to File a Bone Cement Lawsuit?
Showard Law Firm is currently evaluating potential claims against the makers of bone cement. We represent plaintiffs who have suffered as a result of defective medical devices throughout the United States. If you are the victim of bone cement failure, we will fight to recover maximum compensation. There are no legal fees for our services unless we win compensation on your behalf. Call today.
- Complaint: Green v. DePuy Orthopaedics, Inc. et al. https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-06-13-Complaint.pdf
- aaos.org: Projected Volume of Primary and Revision Total Joint Replacement in the U.S. 2030 to 2060. http://aaos-annualmeeting-presskit.org/2018/research-news/sloan_tjr/
- arthritis-health.com: Cemented vs. Cementless Alternatives in John Replacement. https://www.arthritis-health.com/surgery/shoulder-surgery/cemented-vs-cementless-alternatives-joint-replacement