Patient Information about Implantable Medical Devices

Patient Information Cards (PIC) and Patient Information Leaflet (PIL) - Australia

From 1 December 2021, suppliers of implantable medical devices are required to have patient information materials available in the form of PIC and PIL.​

The PIC is used to record the details of the specific device that a patient has implanted – including the name of the device, the manufacturer, the model and batch number and who to contact if they experience any issues. ​

The PIL offers a source of information that can be used to inform discussions on the decision to implant a type of medical device. The leaflet may also be used to provide patients with the name and manufacturer of the device, information about what may happen after the surgery, and information about possible adverse events and malfunctions. Please speak to your doctor about any implant related questions. Your doctor may also provide additional resources to complement PIL.

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iTotal CR Total Knee Replacement System

Patient Information Leaflet

Current Version – 2022/12

 

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