This page contains some Frequently Asked Questions for Health Care Professionals (HCPs).
If you are an HCP, we are happy to address any additional questions. Please click here to email Andy Weymann MD, our Chief Medical Officer. p>
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.
While we continue to study this, the data does not indicate there’s a single, dominant reason why this liner isn’t performing to our standard—such as metallurgy or a manufacturing process. For instance, in the Australian Registry, there’s a range of fairly typical diagnoses, including infection, dislocation, metal sensitivity, loosening/lysis and fracture.
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.
The majority have been used in stemmed total hip replacement. It also can be coupled with both the BHR Hip resurfacing head, as well as the BHR modular head outside the US.
The optional metal liner component within the R3 Acetabular System received FDA Pre Market Approval in November 2008 for use with the BHR Hip resurfacing head. For total hip replacement, it received CE approval in Europe for market evaluation in January 2007 and for full launch in December 2007, and it was included on the Australian Register of Therapeutic Goods in January 2007. Following this, it went through the appropriate regulatory pathways in other markets around the world.
We performed all standard testing establishing the liner’s safety as required by the relevant notified bodies. These tests are generally related to wear performance and mechanical strength.
It was first used in Europe and Australia in 2007 and was launched globally in 2009.
No. The BHR Hip continues to perform well in all registries and peer reviewed data sets. Surgeons who had been using a BHR femoral component with an R3 metal liner can immediately switch to the BHR acetabular component.
There are currently no plans to reintroduce the metal liner component within the R3 Acetabular System. This does not impact other R3 System liners.
We cannot notify patients directly due to privacy rules, but must go through their surgeon to provide information.
Customers should return the product to Smith & Nephew per the withdrawal instructions.
Customers with questions regarding the R3 metal liner should contact their local sales management or sales representative.