FAQs for Patients

This page contains some Frequently Asked Questions for Patients.

Why are you withdrawing the metal liner option for the R3 Acetabular System from the market?

The company has chosen to withdraw the optional metal liner component within the R3 Acetabular System as a precautionary measure following a review of the most recent data. Data collected, including data from the Australian and UK patient registries, indicated the metal liner component within the R3 Acetabular System is not performing as well as we would like.

Was this a mandatory recall?

This is a precautionary and voluntary action.

I've had my hip replaced. How do I find out if mine is an R3 Acetabular System with the optional metal liner?

We recommend that you speak directly with your surgeon regarding your care and to find out which system was used in your particular case.

I am a patient with the R3 Acetabular System with the optional metal liner - what does this mean for me?

We are not recommending any change to current practices. We suggest that you speak with your physician/surgeon.

What types of treatment options are available for me?

Every patient and every case is different. As such, if you have any additional questions we do recommend that you speak with your physician/surgeon to discuss your specific case.

What are you recommending surgeons tell patients who have a metal liner from the R3 System in their hip?

We are recommending physicians maintain their usual follow-up protocol for patients who have undergone hip replacement or resurfacing surgery.

In the United Kingdom, we are in support of the guidance supplied by the Medicines and Healthcare products Regulatory Agency in their Medical Device Alert regarding post-surgical follow-up of patients who have received a metal-on-metal implant. This guidance can be found on their site at http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con143787.pdf.

Whom do I contact for more information?

We recommend that you speak with your physician/surgeon.