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Implant Outlier Process

The NJR supports implant suppliers in the routine post-market surveillance of implants and provides information 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 and is a defined mechanism for contacting the implant manufacturer and regulators in order to provide early warning of issues relating to patient safety, so 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. Person 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.

A Level 1 implant outlier notification process is 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.

A Level 2 implant outlier notification process is 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. Or 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:

 


  

  
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