Tele: 561.316.3330
Breaking Medical Device News

Sunday, October 17, 2021
HomeFDAFDA Advises Patients, Caregivers and Providers of Risk of Breakage of Total...

FDA Advises Patients, Caregivers and Providers of Risk of Breakage of Total Ankle Replacement Device

March 15, 2021

The following quote is attributed to Capt. Raquel Peat, Ph.D., M.P.H., USPHS, director of the Office of Orthopedic Devices in FDA’s Center for Devices and Radiological Health:

“After reviewing long-term data from an FDA-required post-approval study, published literature, real-world evidence and adverse event reports, we’re taking action to advise patients, their caregivers and health care providers of the higher than expected rate of fractures—or breakage—of a plastic component in the Scandinavian Total Ankle Replacement, or STAR Ankle device.

This potential risk of plastic component fracture has been found to occur as early as three to four years after implantation. When compared with other total ankle replacement devices, the higher fracture rate and earlier than expected occurrence of fracture are concerning.

“At this time, we are not recommending removal of any implants. While the risk of fracture of the device is higher than expected, the device remains appropriate for certain patients, such as older patients with lower activity levels. Those who have had ankle replacement surgery with the STAR Ankle should follow their surgeon’s recommendations for follow-up visits and consult with their surgeon if they experience symptoms such as new or worsening pain or instability.

“Protecting the public health is our mission and we’ll continue to work with the device’s manufacturer, Stryker, to better understand the factors that have contributed to the plastic component fracture, ensure patients and medical providers are aware of the potential risks, and identify ways to mitigate that risk.”

Additional Information:

  • Today, the US Food and Drug Administration issued a safety communication providing important recommendations for patients who have or are considering STAR Ankle replacement—a non-cemented device for total replacement of a painful arthritic ankle joint as a result of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis—and their caregivers, as well as information for health care providers who treat and follow patients with a STAR Ankle device.
  • Over the past several years, the FDA has raised concerns with the device manufacturer, Stryker, about the high fracture rate of the plastic component in the STAR Ankle device that was first found during review of a required post-approval study. After a 2014 packaging change made by the manufacturer to address the problem, independent analysis by the FDA shows that the potential for plastic component fracture to occur may exist for all STAR Ankle devices regardless of the manufacture date or packaging, and as early as three to four years after implantation.
  • Results from a long-term, eight-year, FDA-required post-approval study showed that 13.8% of devices had a plastic component fracture at eight years post-implantation. The FDA reviewed postmarket data from over 1,800 medical device reports dating from 2009 (when the device was approved) to December 2020 related to STAR Ankle, as well as data provided separately by the manufacturer that showed 72 out of 244 removed STAR Ankle devices had plastic component fractures.
  • While the long-term fracture rate is not yet known in devices manufactured after the 2014 packaging change, all patients who have the device implanted or are considering getting the device should be aware of the potential risk of plastic component fracture, which may subsequently require re-operation.
  • Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect or experience a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Additional Resources:

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy