Hazard Alert: Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis

Enovis/DJO global is notifying customers of an issue affecting all units of the Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis supplied in the Australian market.

What is the problem?

The STAR Ankle Prosthesis contains a polyethylene (plastic) insert. This insert allows the metal parts of the implant to move and glide against each other smoothly. This insert has experienced a higher-than-expected fracture rate.

This device has been cancelled from the Australian Register of Therapeutic Goods (ARTG) and is no longer able to be supplied.

What are the risks?

When this component fractures, the associated health risks may include:

• Significant pain
• Inflammation
• Soft tissue injury (e.g., blistering)
• Loss of mobility in the ankle
• Grinding or other noises
• Inability to bear weight, and instability in the STAR Ankle.

Damage to the metal components of the prosthesis may mean another operation (revision) might be required.

What should patients do?

Talk to your doctor if you experience any of the symptoms mentioned in the ‘What are the risks’ section above in your STAR Ankle.

What should health professionals do?

Surgeons should contact the Australian College of Orthopaedic Surgeons for a copy of the customer letter. If you have any un-implanted stock – do not use it.

If you suspect a patient has a fracture of the plastic component, consider performing an X-Ray. If X-rays are negative and a plastic fracture is still suspected, a CT (Computed Tomography) scan may be needed.

Clinical presentation (the presence of signs or symptoms) of a fracture in plastic materials can be subtle and sometimes may be diagnosed only through exploratory surgery.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.