Cartiva Synthetic Cartilage Toe Implant

Cartiva Synthetic Cartilage Toe Implant Lawyer

On October 31, 2024, Stryker Orthopedics, on behalf of Cartiva, Inc., issued an urgent FDA Class II Device Recall of all lots of the Cartiva Synthetic Cartilage Toe Implant distributed from July 2016 to October 2024. The FDA Class II Device Recall was necessary due to design issues causing patients to suffer a higher-than-expected rate of serious injuries including pain, nerve damage or fragmentation, implant subsidence, displacement, and the need for revision or toe fusion surgery.

What is the Cartiva Synthetic Cartilage Toe Implant?

The Cartiva Synthetic Cartilage Toe Implant was approved as a medical device in 2016 and was designed as an alternative to traditional joint fusion surgery for patients suffering from arthritis in the big toe (hallux rigidus). The Cartiva Synthetic Cartilage Toe Implant is made from an organic hydrogel polymer with a high-water content, and its elastic and compressive mechanical properties are similar to articular cartilage. The device is intended to replace focal areas of damaged cartilage in the large toe, thereby reducing pain and maintaining range of motion. During surgery, the Cartiva Synthetic Cartilage Toe Implant is placed into the metatarsal head in the first metatarsophalangeal joint via press-fit implantation.

While the concept of the Cartiva Synthetic Cartilage Toe Implant may have initially showed promise, the company aggressively marketed and advertised the device as a safe alternative and superior option to toe fusion surgery. Since approval of the device, thousands of patients across the country have begun reporting severe complications following the implantation of the Cartiva Synthetic Cartilage Toe Implant with many injured patients requiring additional surgeries to remove or replace the device and to fuse the toe.

The rights to manufacture and sell the Cartiva Synthetic Cartilage Toe Implant have changed over time. In 2016, Cartiva, Inc. designed the Synthetic Cartilage Toe Implant and began marketing the product in the United States. In 2018, Wright Medical Group N.V. acquired Cartiva, Inc. for $435 million in cash. The acquisition included the rights to manufacture and sell the Cartiva Synthetic Cartilage Toe Implant. In 2020, Stryker Orthopedics acquired Wright Medical Group N.V. for $4.7 billion and along with this transaction obtained the rights to market and sell the Cartiva Synthetic Cartilage Toe Implant.

Injuries Associated with the Cartiva Synthetic Cartilage Toe Implant

Physicians and patients have reported significantly higher rates of failure of the Cartiva Synthetic Cartilage Toe Implant than was previously reported in clinical trials conducted by Cartvia, Inc. Many patients have experienced serious and painful complications after receiving the implant including:

Complete implant failure
Need for revision or toe fusion surgery
Implant subsidence or displacement
Bone loss (lysis) around the implant site
Chronic pain and swelling
Nerve damage or fragmentation
Limited mobility and stiffness
Inability to walk without assistance

These complications often result in significant pain, immobility, lifestyle changes, and expensive medical treatment. If you’ve experienced issues with the Cartiva Synthetic Cartilage Toe Implant, it is very important to seek both medical and legal advice as soon as possible.

Cartiva Synthetic Cartilage Toe Implant Recall

On October 31, 2024, Stryker Orthopedics (“Stryker”), on behalf of Cartiva, Inc., issued an urgent FDA Class II Device Recall of all lots of the Cartiva Synthetic Cartilage Toe Implant distributed from July 2016 to October 2024.

That same day, Stryker sent a safety notification to surgeons and hospital managers explaining that the company had become aware of published medical literature and data including post-marketing adverse events which demonstrated a higher than anticipated rate of certain injuries with the Cartiva Synthetic Cartilage Toe Implant. The injuries include revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation. The company also disclosed that the frequency of device failures requiring surgical intervention had surpassed the rates initially reported in the pre-market approval process and post-approval studies.

The FDA Recall included all manufacturing lots of the Cartiva Synthetic Cartilage Toe Implant distributed over an 8-year period from July 2016 to October 2024. All sizes of the device were included within the FDA Recall including the 6 mm, 8 mm, 10 mm, and 12 mm sizes. The affected units have the following primary device identifier (PDI) and catalog numbers:

PDI 00852897002328, CAR-06-US (6mm)
PDI 00852897002021, CAR-08-US (8mm)
PDI 00852897002038, CAR-10-US (10mm)
PDI 00852897002335, CAR-12-US (12mm)

As part of the FDA Recall, healthcare providers are advised to monitor patients for symptoms of implant failure, which can include pain; difficulty walking; stiffness, swelling, or weakness in the big toe joint; and skin reactions. Individuals experiencing symptoms should consult with their surgeons immediately and work with their healthcare providers to report any adverse event via MedWatch which is the FDA’s Safety Information and Adverse Event Reporting Program.

Who May Be Eligible to Bring a Claim Against Cartiva?

You or a loved one may be eligible to pursue a legal claim for injuries suffered from the Cartiva Synthetic Cartilage Toe Implant if:

You received a Cartiva Synthetic Cartilage Toe Implant.
You experienced implant failure, pain, or other complications.
You required revision or corrective surgery.
Your quality of life was negatively impacted by the device.

Claims against Cartiva and any related companies typically fall under product liability law, which holds manufacturers accountable for injuries caused by defective medical devices.

Steps to Pursuing a Cartiva Synthetic Cartilage Toe Implant Case

Undertaking an investigation of a potential product liability claim may feel overwhelming, but our legal team will guide you in every step of the way. Here’s generally how a product liability case works:

Free, No Obligation Consultation: Contact our office to schedule a free, no-obligation case review. We will listen to your story and provide an initial evaluation as to whether we believe you have a viable claim. If so, we will also provide a recommendation for how to best handle your individual case.
Medical Records Review: With your permission, our legal team will obtain and review your relevant medical records necessary to identify the implant at issue and to establish the cause and extent of your injuries. Initial record requests focus on your relevant orthopedic surgeries and care including follow-up treatment.
Filing the Claim: If eligible and with your agreement, we will prepare a complaint to be filed necessary to assert a legal claim for damages on your behalf against the manufacturer of the Cartiva Synthetic Cartilage Toe Implant.
Litigation, Trial & Settlement: We will litigate your case through the discovery process and prepare to take it to trial to pursue maximum recovery. If we are able to negotiate a fair settlement of the claim, we will advise you and provide our recommendation on whether to accept or reject the settlement offer.

Cartiva Synthetic Cartilage Toe Implant Lawsuit

At Fitzgerald Law Group, we are committed to standing up for individuals injured by defective medical devices and prescription drugs. Our experienced product liability attorneys are here to help guide you through the legal process and fight for your rights.

If you or a loved one received a Cartiva Synthetic Cartilage Toe Implant Case and have suffered complications or required revision surgery, you may be entitled to significant compensation including reimbursement of medical expenses, lost wages, pain and suffering, disability and permanent injury, punitive damages, and wrongful death.

To speak with an experienced Cartiva Synthetic Cartilage Toe Implant lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (207) 874-7407, or complete the contact form on this website for a free, confidential, case assessment.