Just as Stryker Corporation was announcing the acquisition of Wright Medical and its TARS ankle system, the company warned of plastic fracture problems with its STAR (Scandinavian Total Ankle Replacement) system.
Stryker issued a “Safety Communication” on October 11, warning of higher than expected risk of polyethylene fracture. Click here for the notice.
The communication stated the company became aware of data indicating that patients who’d received Stryker’s STAR Total Ankle Replacement distributed prior to August 1, 2014, “may experience a higher than expected risk of polyethylene fracture due to potential increase in polyethylene oxidation prior to or after implantation and potentially the implant geometry.”
Additional factors that may have contributed to the fractures are “component malalignment, surgeon learning curve, and reduced insert thickness.”
August 2014 is about the same time that Stryker acquired Small Bone Innovations, Inc., and STAR from the Viscogliosi Brothers.
Fractures
The Safety Communication added that the company identified a 13.79% polyethylene fracture rate at the eight-year follow-up in the post-approval study for the device. They also found more than 100 polyethylene fractures reported in the FDA MDR (Medical Device Reporting) database.
Those fracture rates “occurred substantially more often than with comparable total ankle replacement and with fixed bearing total ankle replacements.”
The polyethylene component manufactured and distributed subsequent to August 1, 2014 is not subject to the safety notice.
The final non-foil packed STAR polyethylene components were produced on July 10, 2014 and had a shelf-life of five years. Those components expired on July 10, 2019.
Risks
Risks associated with the fractures include:
- “Significant pain, newly developed and/or persistent for a significant time
- Inflammatory response, newly developed and/or persistent for a significant time
- Soft tissue injury e.g. blistering
- Loss of mobility in the operated ankle
- Possible damage to the metal components of the ankle after the polyethylene fractures, requiring revision of the entire total ankle replacement”
Two of the reported subjects had a fracture implant diagnosed only at exploratory surgery.
Providers were told they are required to inform users of the safety notice and sign a form included in the notice. The form has to be returned even if there are no affected products at the providers’ facility.
Patient Symptoms
Patients should be made aware that the fracture may be subtle. “The following symptoms may indicate that a complication has occurred:
- Increased pain
- Inability to bear weight
- New onset grinding or other noises
- Worsening instability in the ankle”
The company established a dedicated call center for patients. The number is 1-978-274-7633. Providers are asked to keep the company informed of any adverse events by emailing strykerortho6463@stericycle.com.
Lawyers and Regulators
The personal injury network got right to work. The website, aboutlawsuits.com, reported on November 13 that as a result of these problems, “it appears likely that a number of individuals who received the device may now pursue Stryker ankle replacement lawsuits, alleging that design defects caused the fracture or premature failure of the device.”
There is no word whether or not the safety issue with Stryker’s STAR system will have any impact on Department of Justice regulators evaluating possible anti-trust issues between Wright’s TARS ankle system and Stryker’s STAR ankle system. We reported on November 8, 2019, that Wall Street analysts had mentioned that the proposed Stryker Corporation purchase of Wright Medical will trigger a regulatory review and may result in a request for Stryker to divest itself of one or the other, though most likely STAR.
I have a Star ankle replacement 5 years old. The plastic inside has fractured & migrated outside the prosthesis. Surgeon plans to replace plastic component. Is this fix possible? Or will I have to have total new device?
Hi Dale,
Sorry to read about your issue. From what I’ve read, it sounds like surgeons can replace the polyethylene component unless the fracture has caused damage to the other parts. In this case, they would have to do a complete revision. I too am having significant problems with my Stryker STAR ankle replacement. My surgery was in June 2013, and I have confirmed one of the parts has been recalled. My surgeon did not send me the Recall Notice, only a note saying he was closing his practice with no referrals to another Doc. I have contacted Stryker for a list of Surgeons who carry their prosthetics and they still have not gotten back to me. Could you please share the name of your surgeon? Thanks so much. I am desperate to have it repaired before it gets worse. Thanks so much.
Can anyone recommend a Surgeon in the US who has done revision surgery of the recalled Stryker Star Ankle replacement Sliding Core? Thanks so much.
Diane,
My ankle surgeon is Jeff Taylor. His office is North Texas Podiatry Associates. He is located in Southlake, Tx. Southlake is a suburb of Dallas/ Ft. Worth. He is an awesome Dr. I do hope you are able to have your ankle repaired. I had the STAR ankle replacement Dec 2016.
I had my ankle replaced in Oct 2013 with the Stryker total ankle replacement. I’ve had nothing but problems so much so that I’ve had 3 surgeries after that, my last surgery was Sept 3 2020 that surgery was another total ankle replacement, it was with a new surgeon and the replacement ankle was not a Stryker ankle. My advice is to get a second opinion with a surgeon that doesn’t use the Stryker ankle. Revisions didn’t seem to help me my foot was slowly falling off my leg
I had the star done in 2013 was good for several years and then horrible. My surgeon is awesome and works for center for foot and ankle restoration in Dallas ,Tx Dr. Noack my issue is not with him but my injury was a workers compensation situation and I can’t seam to get approved for him to replace but he is a great Dr.