Menu & Search
Speak to our friendly team
Contact Us Now

The Medicines and Healthcare Products Regulatory Agency (MHRA) today recalled a medical device used in spinal fixation systems. Orthopaedic spinal surgeons used the device to correct deformities or repair degenerative diseases in the spine. The USS II Polyaxial 3D Head rings have been prone to cracking. This may result in the system loosening before the bone has a chance to heal.

Device Recalled in November 2019

At the end of last year DePuy Synthes issued an urgent field safety notice for the heads following repeated complaints of the implants cracking. They therefore voluntarily recalled their devices and advised surgeons to perform routine clinical follow-ups with patients who had the device implanted.

A DePuy representative, in November 2019 provided the following statement; “At DePuy Synthes, our first priority is to our customers and their patients. On November 11, 2019 DePuy Synthes voluntarily issued a medical device product removal of certain lots of USS II Polyaxial 3D Heads in several markets…These devices are part of a pedicle screw fixation system designed to stabilize the spine. The devices were recalled due to complaints of intra-operative sounds and cracking of the ring that helps to stabilize the spine. DePuy Synthes promptly notified relevant regulatory agencies and has begun notifying customers.”

Medical Device Alert

Trusts in the UK supplied with the affected spinal medical device received the alert today. The next steps are crucial to identify any faulty devices promptly. The alert advised Trusts to:

  • Identify and quarantine all affected devices within 2 weeks.
  • Follow up patients implanted with affected devices.
  • Contact all patients who have had the device implanted for less than two years, within three months to discuss implant failure symptoms.
  • If they do not have symptoms, an annual review for at least two years after the date of implantation.
  • X-ray or CT scan anyone with symptoms to confirm an implant failure. Then explore treatment options using clinical judgement and patient consultations. Annual patient reviews for up to five years.

Your doctor or surgeon will consult with you and decide the best course of treatment. So, speak to them if you are concerned that you have been fitted with a USS II Polyaxial 3D Head.

If you are still concerned about a defective medical implant, speak to our experts to find out how to make a claim.

Start Your Claim Today1904556600
Tell us about your case

Just send us a little bit about yourself and your claim and we will respond within 24 hours.

Get In Touch
Latest News

Covid-Friendly Cancer Treatment

NHS England appears to be responding to the growing concerns over delays to cancer treatment during the coronavirus pandemic. NHS England are investing £160m […]

Read More

Welsh Government Accused of Neglecting Patients

The Welsh Conservatives have accused the Labour-led Welsh government of neglecting patients. This comes after a Freedom of Information request reveals that more than […]

Read More

Negligent Approach to Social Care in the Pandemic

A report has accused government of a “slow, inconsistent, and at times negligent approach” to social care in the COVID-19 pandemic. The Public Accounts […]

Read More

Take a look back through our complete news archive

Follow us on Twitter

At least 21,000 people are awaiting ADHD assessment, with some waiting up to five years.

The NHS is investing £160m on new “Covid-friendly” cancer treatment, as an apparent response to growing concerns over delays of cancer treatment

Load More...