This page contains some Frequently Asked Questions for Patients.
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.
This is a precautionary and voluntary action.
We recommend that you speak directly with your surgeon regarding your care and to find out which system was used in your particular case.
We are not recommending any change to current practices. We suggest that you speak with your physician/surgeon.
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.
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.
We recommend that you speak with your physician/surgeon.