Weitz & Luxenberg is accepting cases from clients harmed by the Stryker Cartiva Synthetic Cartilage Implant (SCI). The recalled device is reported to have a “higher-than-expected occurrence rate” of hazards. This includes higher revision and removal rates. (1) Available in the U.S. since 2016, the device is used to treat big toe arthritis. (2)
If you or a loved one has been harmed by a Stryker Cartiva SCI, you should consider filing a lawsuit to gain compensation for your injuries from this device failure. Reach out to us now at (917) LAWYERS.
“Defective products can do serious harm to people. The companies that make money off of those products should be held responsible. That is what our legal team at Weitz & Luxenberg does. We hold companies accountable for the products they make, for the decisions they make, and for the damage they do,” says Ellen Relkin, partner and chair of W&L’s Drug and Medical Device Litigation practice area.
The Cartiva Implant
The Cartiva Synthetic Cartilage Implant is a polyvinyl alcohol implant used in the treatment of osteoarthritis and is intended to be an alternative to fusion of the joint. The implant entered the U.S. market in July 2016 after a study which allegedly showed up to 87% successful outcomes at 2 years after the implantation. However, after hitting the market here, reports to the U.S. Food and Drug Administration (FDA) and published studies began showing concerns as to safety and efficacy. (3)
The implant was designed and originally sold by Cartiva Inc., which was sold to Wright Medical in October of 2018. Wright Medical was acquired by Stryker in November of 2020 and Stryker is responsible for the liability of the Cartiva Inc. and Wright Medical for these implants. (4)
Defective Cartiva Device Failure
Cartiva toe implant device failure is mainly due to subsidence, “where the implant slips into the bone.” This “can lead to increased pain and discomfort.” It typically means limited mobility, and the need for an additional surgery — a revision — to correct. (5)
In fact, the Cartiva implant “is known to have higher than originally reported complications,” reports the American College of Foot and Ankle Surgeons. In its study, researchers explained the most reported device problems were: (6)
- Unspecified device issue — 55%
- Device migration — 20%
- Implant failure/defect —18%
- Incompatibility — 7%
Underscoring the point, a study from the journal Foot & Ankle Orthopaedics found, “Significant radiologic subsidence with lysis around the implant, erosion of the proximal phalynx countersurface as well as recorded implant wear are harbingers for concern in the long term.” (7)
This means there is noticeable sinking of the implant on the X-ray, and bone loss around it. The surface of the nearby bone is being worn away, and the implant itself shows signs of wear. These issues often cause problems for your health in the long run.
Experienced pain, implant failure, or revision surgery after a Cartiva toe implant? Contact Weitz & Luxenberg to see if your injury qualifies for a claim.
Get Your Free Case Evaluation TodayDefective Toe Implant Recall Issued by Stryker
In an urgent 2024 recall notice, the manufacturer indicated the recall was intended to provide “updated postmarket safety data.” Stryker also acknowledged documented negative health effects from Cartiva SCI failure including: (8)
- Revision.
- Removal.
- Implant subsidence.
- Displacement.
- Pain.
- Nerve damage.
- Fragmentation.
What Is the Cartiva SCI Device?
“The Cartiva SCI device is comprised of an organic hydrogel polymer made of polyvinyl alcohol and saline. Cartiva SCI has a high water content, and its elastic and compressive mechanical properties are similar to articular cartilage,” according to the manufacturer. (9)
The entire device is comparable to a bullet in size. Stryker describes it as “a molded cylindrical implant.” This implant “is placed into the metatarsal head in the first metatarsophalangeal joint via press-fit implantation.” (10)
Side Effects from Recalled Cartiva SCI
The FDA included a summary of the potential adverse effects of the Cartiva SCI in its device approval. That long list includes the following orthopedic complications: (11)
- Fracture.
- Implant loosening, dislocation, or dislodgement.
- Incomplete correction.
- Incorrect placement.
- Joint irritation, instability, malalignment.
- Pain.
- Scars.
- Blood loss and infection.
- Bone loss.
- Cysts, including bone and around a joint.
- Damage to adjacent nerves, arteries, and veins.
- Effusion.
- Numbness in toes.
- Recurrence of deformity.
- Subsidence.
- Swelling.
If you have a Cartiva SCI implant and have experienced any of these issues, speak to your doctor. You may need to have it removed.
While it may be necessary to have a removal or revision surgery, make sure your surgeon and hospital take steps to preserve it. The device is important evidence for any related legal claims. On behalf of its clients, Weitz & Luxenberg contacts the hospital pathology department and surgeon and arranges for the proper packaging and shipping to a secure medical storage facility.
W&L Can Help People Injured by Cartiva Implant
W&L has a 40 year history of successfully helping clients injured by defective medical devices. W&L has won millions in settlements and verdicts on their behalf. We fight for your rights and to help you obtain compensation for your injuries.
W&L handles many defective device litigations, and we have successfully gone up against Stryker in numerous implant cases:
- We played a key role in obtaining a settlement of more than $1 billion for patients injured by their Rejuvenate and ABGII modular hip implants.
- We also sued and had very large confidential settlements for our clients over their recalled LFIT Cobalt Chromium V40 Femoral Heads as well as successful settlements arising from their ceramic-on-ceramic hip implants.
It is our first priority to help clients get the justice you deserve. Contact us today by calling (917) LAWYERS or filling out the form on this page. Your initial consultation is free. We want to help you.