Search  Search
Font Size:     Small text Medium text Large text   email pageemail pageprint pageprint page
IN THIS SITE...

Implant Outlier Process

 

The NJR supports medical implant suppliers in the routine post-market surveillance of their implants and provides implant outcome information also to clinicians, patients, hospital management and the regulatory authorities. The NJR Implant Outlier Process identifies hip and knee implants which fall outside designated patient time incidence rate (PTIR) confidence intervals, which is a defined mechanism for initiating contact with the implant manufacturer and regulators, in order to provide early warning of any issues relating to patient safety, so that early appropriate action can be taken.

To note: the Implant Outlier Process is not a substitute for pre-market properly designed and conducted randomised trials for new implant designs. Patient time incidence rates (PTIR) is the number of new cases (in this context revision procedures) per population at risk in a given time period. The NJR expresses the PTIR as the number of revisions per 100 patient years at risk.
 
There are two levels of outlier notification:

Level 1 implant outlier notification process - triggered when an implant has a patient time incidence rate (PTIR) of at least twice the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR.

Level 2 implant outlier notification process - triggered when an implant has a PTIR of at least twice the overall PTIR, for implants that have been used in less than 100 primary operations in the NJR. It can also be triggered when an implant has a PTIR of at least one and a half times the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR. 

 


 

 

Implant Outlier Process documentation:

 

  

  
Copyright © 2020 National Joint Registry Terms and conditions Privacy policy Login