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18 November 2019 | Comment | Article by Mark Harvey

Leading med tech company, Stryker, issues urgent field safety notice

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 1970s, 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.

Hugh James is currently representing several hundred people in claims against DePuy International Ltd in relation to a metal on metalhip prosthesis. We are also investigating other medical devices including:

  • an artificial knee by Smith & Nephew called Oxinium Genisis II,
  • defective surgical mesh used to treat pelvic organ prolapse and urinary incontinence,
  • defective intraocular lenses manufactured by Oculentis BV, and supplied by Optical Express,
  • upper limb joint replacement implants such as elbows that use a medical compound called PEEK,
  • defective heart assist and defibrillator devices,
  • the Essure contraception device, and
  • failed gastric bands.

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.

Author bio

Mark Harvey is a Partner in the claimant division. He has obtained compensation for many individual victims of common but defective consumer products as well as victims of accidents overseas and arising out of travel generally.

Mark is the court appointed lead solicitor coordinating over 1,000 claimants in a group litigation order (GLO) arising out of the recall and health alert relating to the French manufacturer’s PIP silicone breast implants.

Disclaimer: The information on the Hugh James website is for general information only and reflects the position at the date of publication. It does not constitute legal advice and should not be treated as such. If you would like to ensure the commentary reflects current legislation, case law or best practice, please contact the blog author.

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