Device safety informationMHRA
Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement safety warning over a software fault
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
What to do now
The issue with Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee is in its software or user interface.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/005). Quoted as issued.
Summary
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
The risk
Device Details ORIGIN is a patient-matched total knee replacement prosthesis available in posterior stabilised (PS) and cruciate retaining (CR) variants. Affected catalogue and lot numbers: Refer to the Field Safety Notice (FSN) issued by the manufacturer for details on the affected devices.
Advice for healthcare professionals
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement. The ORIGIN PS variant, raised as a level 1 outlier, demonstrates a revision rate (per 100 patient years) that is at least two times higher than all other bicondylar knee replacements in the UK. This issue currently appears to be UK-specific as other international registries do not show the same increase in early revision surgeries.
The MHRA has conducted a review of all available evidence and has requested further investigation by the manufacturer. The root causes behind the UK revision procedures are yet to be fully established and the underlying reasons behind the differences between regions is yet to be understood.
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. This will be until such a time that further evidence is gathered and assessed.
The devices being recalled are outlined in the FSN issued by the manufacturer.
Actions for healthcare professionals (particularly surgeons) and hospitals
Follow the actions set out in the FSN .
Identify patients implanted with the affected devices.
Contact and inform patients 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.
Surgeons are encouraged to recognise that when interpreting post-operative x-rays for the ORIGIN, the insert may demonstrate variations in thickness, asymmetry or obliquity per design; as a patient-matched device, this interpretation may differ to more general total knee arthroplasty systems.
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
Open the MHRA notice
Questions
Why has Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee been recalled?
The issue with Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee is in its software or user interface. Software faults can lead to wrong readings, missed alarms or incorrect settings.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.