23 Apr 2024

MHRA Field Safety Notice - Symbios ORIGIN® posterior stabilised patient-matched total knee replacement device

MHRA Field Safety Notice - Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, DSI/2024/005

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 Field Safety Notice (FSN) issued by the manufacturer.

Further details available here.