Patient Notifications

Patient notices about procedures

Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device

The MHRA was alerted to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement. The ORIGIN PS variant demonstrates a revision rate (per 100 patient years) that is at least two times higher than all other bicondylar knee replacements in the UK.

As a precautionary measure, Symbios Orthopédie SA has initiated a voluntary suspension of all further sales and implantations, alongside a recall of all variants of the ORIGIN device family within the UK<.br>
For patients implanted with the ORIGIN PS variant, there is an increased risk of requiring an operation to replace the device.. The data shows 8 revisions from 149 primary implantations over a period of approximately 6 years. Patients have undergone revisions for aseptic loosening, malalignment, stiffness, and instability.

For patients implanted with the CR variant, there is no evidence to suggest an increased risk of revision, however the manufacturer has opted to expand the scope to include the entire ORIGIN device family as a precaution.

Nuffield Health have contacted all patients and informed them that they should return for a follow up visit within 12 months and that they will soon be invited by the NJR to complete an evaluation of their knee joint replacement.

CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture

The Medicines Health and Regulatory Authority (MHRA) recently published a field safety notice (FSN) relating to CPT Hip System Femoral Stem 12/14 Neck Taper Implants. Within the FSN it details that evidence shows there is an increased risk of postoperative periprosthetic femoral fracture (PFF). The risk of this complication has risen from 0.7% to 1.4%. While the risk of this fracture occurring is low, this is more than twice the risk of PFF compared to similar PTS stems that are not made of cobalt chromium.

There are no specific actions for patients already implanted with a CPT Hip System. Continue to follow the guidance and advice of your surgeon.

However following this publication, the manufacturer will cease to supply these implants in December 2024. Nuffield will no longer be implanting these devices as a precautionary measure.

Metal on metal hip replacements

The Medicines Health and Regulatory Authority (MHRA) has revised its guidance on reviews for patients who have undergone metal on metal implant surgery.

The Medicines Health and Regulatory Authority (MHRA) has revised its guidance on reviews for patients who have undergone metal on metal implant surgery. As a result of the changes, all patients with these implants are now advised to have their blood metal level tested according to MHRA guidelines and some may require ultrasound or MRI scans.

As a result of this new guidance, Nuffield Health have contacted patients who we believe received Metal on Metal Implants at our hospitals.

If you were treated in a Nuffield Health hospital for a joint replacement and believe you received a metal on metal hip implant but have not yet been contacted by us, you can find out if you might be advised to be tested by contacting the Matron at the Nuffield Hospital you had your hip surgery. Contact details can be found here.

Transvaginal mesh for repair of anterior or posterior vaginal wall prolapse

Following guidelines issued by NICE regarding transvaginal mesh repair of anterior or posterior vaginal wall prolapse, we will be fully implementing their recommendations and will no longer be using mesh in this procedure.

The NHS are now responsible for commissioning specialised services for women with complications of mesh inserted for urinary incontinence and vaginal prolapse. A list of hospitals selected to provide these specialist services and a series of patient information leaflets can be accessed here: https://bsug.org.uk/pages/for-patients/mesh-information-leaflets/156. This information is aimed to support decision making and we encourage all patients considering this type of surgery to use these leaflets as a basis for discussion with your Consultant, GP, hospital care team and family or friends.

For patients who have already undergone their procedure, there is currently no guidance from regulators regarding what if any action should be taken. Until such guidance is provided, we are not advising any interventions but encourage any women who have concerns and were treated at one of our hospitals to get in touch with us by calling 0300 123 1907.

Cataract lens implants with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs)

The Medicines & Healthcare products Regulation Agency (MHRA) have been made aware there is some concern that an increased pressure in the eye has been found in a small number of patients who have received EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs) since September 2022. Having high pressure in your eye can lead to damage to your optic nerve and vision loss if left untreated.

In response to this, Nuffield Health have contacted patients who we believe received these lenses and invited them to an appointment to have their eye pressure measured as soon as possible.

If you have attended a Nuffield Health hospital for eye surgery since September 2022 and believe you received an EyeCee One preloaded or EyeCee One Crystal preloaded intraocular lens, but our team has not been able to contact you, please contact the Nuffield Health Hospital where you had your eye surgery. They will be able to advise you if eye pressure testing is required and if so an appointment can be arranged. Contact details can be found here.

Total Knee Replacement surgery using Zimmer Biomet NexGen® Stemmed Option Tibial Components

The National Joint Registry (NJR) and Zimmer Biomet (the manufacturer), have identified that the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral, have a higher revision rate than other total knee replacements.

In response to this, Nuffield Health is contacting patients who we believe have been implanted with these combinations of components and invite them to an appointment with an orthopaedic surgeon to review their knee.

If you have attended a Nuffield Health hospital for knee replacement surgery and believe you received a Zimmer Biomet NexGen® Stemmed Option Tibial Component, you will be contacted in the coming weeks.

If our team has not been able to contact you, please contact the Nuffield Health Hospital where you had your knee surgery. They will be able to advise you if an appointment needs to be arranged. Contact details can be found here.

Patient notices about case reviews

Professor David Galloway review
An independent historical review of a select number of Professor David Galloway’s patients at Nuffield Health Glasgow Hospital has taken place. This happened after two of Professor Galloway’s patients at Nuffield Health had a rare complication associated with the positioning of their gastric-band. Professor Galloway retired from his practice at Nuffield Health in 2015. For any additional patients of his who have concerns or questions, please contact our Glasgow Hospital team on 0141 5306133, Monday to Friday between the hours of 09:00-17:00.

Professor Derek McMinn investigation

Following recent media coverage with allegations against a former consultant, Professor Derek McMinn, we would like to reassure patients that we will support the ongoing investigation by the GMC and BMI Healthcare.

Professor Derek McMinn was suspended in March 2019 from working at BMI Healthcare’s Edgbaston Hospital. This hospital was owned by Nuffield Health until 1 February 2008 and Professor Derek McMinn therefore worked with Nuffield Health up until this time when the hospital was sold to BMI Healthcare.

The care of our patients is our number one priority and we understand these allegations may be distressing for Prof McMinn’s former patients and their relatives. If any information concerning individuals that relates to patient harm is identified as the criminal investigation progresses, we will respond to the people concerned and provide any support they need. Please contact us 020 7935 0894 (selecting option 4) if you would like more information.

For further information, please email us revalidation@nuffieldhealth.com