Pathway for raising concerns to the NJR in relation to poor implant performance

The primary function of the NJR is to gather data about joint replacement implant performance and then analyse it in order to minimise avoidable patient safety issues. The formal processes to achieve those aims are clearly set out and rely on comprehensive data collection and analysis, followed by an escalation of any concerns where certain pre-determined performance thresholds are breached.  

There are often other less formal concerns raised about an implant variant and this happens on a fairly regular basis, and it is important that every surgeon and hospital performing joint replacements is aware of how they should bring any concerns to the attention of the NJR in a way which will be taken seriously and investigated appropriately. There have been instances where this has apparently not occurred satisfactorily, and for that reason the formalisation of the process below has been recently discussed and agreed by the BOA Executive, and with the presidents of each of the orthopaedic specialist societies. 

Agreed process for bringing concerns to attention of the NJR

Any surgeon who has concerns that an implant brand, or any specific variant within the brand, appears to have a high failure rate should raise their concerns in writing, by sending an email to the NJR Medical Director, the Chair of the NJR Implant Scrutiny Committee and copying it to the NJR Director of Operations:  

• NJR Medical Director – Timothy.Wilton@njr.org.uk 

• Chair of the NJR Implant Scrutiny Committee – Colin.Esler@njr.org.uk 

• NJR Director of Operations – Chris.Boulton@njr.org.uk 

Similarly, if a concern is identified about any implant brand, or variant within a brand, by any staff member within a hospital, the concern should be raised formally by the same process as outlined above. They are welcome to do this either themselves personally or by raising the issue with their NJR Clinical Liaison Lead or Lead Surgeon in their department, who can support them in sending the email to the above.  

On receipt of the email, the NJR will formally acknowledge the concerns raised and will instigate an investigation as appropriate, with a view to assessing the implant/construct in question. The NJR will then respond in accordance with the findings of the investigation. 

Rationale for advising of this formal process

Some approaches have been made in the past been on an informal basis, at meetings of the BOA and/or specialist associations. Informal approaches such as these, carry the risk that they may not be formally followed up nor documented, or may be regarded as having been resolved by the discussion. It is therefore important that if a concern regarding implant performance is raised in this more formal way.  

Also in the past, concerns about implants have sometimes been raised with members of the ODEP panel. It is perfectly legitimate to raise an issue with ODEP about ratings for implants, but equally it is important that those raising any concerns appreciate that ODEP and the NJR are completely separate organisations and that they work in different ways, accessing data by quite different routes.  

The NJR collects data about all joint replacement operations performed in England, Wales, N Ireland, IoM and Channel Islands. On receipt of any concern raised, these data can be analysed and re-analysed by the NJR team in many different ways to investigate concerns with the performance of any implant.  

In contrast, ODEP receives the information about implants in a certain format and as presented by the manufacturing company, for the purpose of getting an ODEP rating.  

Manufacturers can and do use data from published (and unpublished) studies and other national registries for their submissions to ODEP, but do not always use NJR data. Such data are presented to ODEP by the manufacturer on a voluntary basis and therefore it may be that the data cannot answer the question being raised by the surgeon and may not be open to further interrogation. Similarly, it may be that the particular implant variant of concern may not have had an application made to ODEP for a rating either recently or perhaps at any time.  

For these reasons it is important that people making an approach about an implant of concern should always do so to the above NJR senior team directly, and decide themselves if they also wish to approach ODEP about the same issue, and if so that the NJR team be advised of this. 

Should you have any queries or concerns about this process please contact: 
Chris Boulton – NJR Director of Operations by email: Chris.Boulton@njr.org.uk