In October 2019 Stryker, one of the world’s leading medical technology companies, has issued an urgent field safety notice in relation to its STAR (Scandinavian Total Ankle Replacement).
Total Ankle Replacements (TAR’s) gained in popularity in the 1970’s, and are now going through an evolution. A new wave of TARs are replacing ankle fusions (arthrodesis) which have historically been the main surgical treatment for ankle osteoarthritis.
TAR’s are generally performed on patients with post traumatic osteoarthritis. They are not as widely used as hip and total knee replacements (TKR’s). Of the 29,000 patients who present with osteoarthritis in the UK, approximately 3000 will undergo surgery through the NHS. It has however been reported that the number of fusion surgeries remains static but that the number of TAR’s has been increasing.
Stryker’s STAR system is considered a second generation design first developed in 1978. It originally consisted of two components but through modifications has now become a three component design with the addition of the polyethylene spacer. Over the thirty years that it has been on the market approximately 30,000 STAR systems have been sold.
Manufacturers are now on to the third and fourth generation devices. The STAR makes use of an ultra-high molecular weight polyethylene (UHMWPE). This is a three component system, making use of the polyethylene spacer.
Stryker has become aware of data from patients implanted with the STAR device, distributed prior to 1 August 2014 that there is a higher than expected risk of polyethylene fracture. If you were implanted with a Stryker STAR prior to 1 August 2014, it is worth speaking to a solicitor who specialises in joint replacements to find out your legal rights.
The safety communication can be viewed here.
Stryker is warning that the potential risks associated with the polyethylene mobile bearing fracture include:
- Significant pain, whether this pain is a new development or it has been experienced for a significant time,
- An inflammatory response, whether this inflammation is a new development or it has been experienced for a significant time,
- Soft tissue injury e.g. blistering,
- Loss of mobility in the operated ankle,
- Possible damage to the metal component of the ankle after the polyethylene fractures requiring revision of the entire TAR.
It has also given the additional warning that the fracture of the polyethylene part of the TAR can be subtle. There does not necessarily have to be a significant injury to have a polyethylene part of the ankle fail. Symptoms indicating that a complication has occurred are:
- Increased pain,
- Inability to bear weight,
- New onset of a grinding sound or other noise,
- Worsening instability in the ankle.
In the event that a patient experiences any of the above symptoms they are advised to contact their GP/surgeon.
If you have had a Stryker total ankle replacement and believe you have developed symptoms of pain, loss of function or instability as a result, you may be able to make a claim against the manufacturer.
Get in touch with our harmful products team using the envelope or telephone buttons on this page to find out if you are eligible to claim.