Smith & Nephew Announcement about THR femur component for BHR revisions 9/2012
Why was there a modification to the indications for use for the BIRMINGHAM HIP Modular Head?
We have modified the indications for use of the BIRMINGHAM HIP Modular Head after a careful review of available data and the decreased utilization of this component by customers in all markets where it has been sold.
Available data sources show that from 2003 to 2009, the BIRMINGHAM HIP Modular Head performed within the statistically acceptable range set forth by the UK’s National Institute for Health and Clinical Excellence (NICE) benchmark of a 1% revision rate per year. Recent registry data that we received indicates an increasing revision rate trend in primary THA from 2010 onwards.
How should the BIRMINGHAM HIP Modular Head be used going forward?
Surgeons will only use it in cases where a BIRMINGHAM HIP Resurfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an uncemented SYNERGY stem.
Is this the same basic issue other companies have had with their failed Metal on Metal (MoM) hip implants?
While metal sensitivity is represented in the reasons for revision, when used with an uncemented SYNERGY stem, the data show that it performs well clinically.
I have used stems other than SYNERGY with the BIRMINGHAM HIP Modular Head device. What does this mean for these patients and why was only SYNERGY selected?
Our recommendation is based on our analysis of all relevant data. The data show that, if combined with the uncemented SYNERGY stem, the revision rate is acceptable and comparable to other clinically successful hip implants on the market. We recommend physicians maintain their usual follow-up protocol for patients who have undergone hip replacement surgery using the BIRMINGHAM HIP Modular Head with a stem other than the SYNERGY stem.
How are patients being notified?
We cannot notify patients directly due to privacy rules; therefore, we must rely on surgeons to provide information to them. To assist with your patient communications, Smith & Nephew also provides FAQs specifically for patients on this website.
What follow-up measures do you recommend for surgeons whose patients have a BIRMINGHAM HIP Modular Head in their hip?
Clinical follow-up of THA patients by their surgeon is good practice and a matter of routine protocol. In addition, some medical groups or regulatory bodies recommend additional monitoring of patients with some implants. This field action does not change current practices for patient follow-up care for this component. Any patient monitoring or treatment that a health care provider decides to undertake should continue to be managed as part of ordinary patient after-care arrangements.
Is the BIRMINGHAM HIP Resurfacing (BHR) component affected by this action?
No. The BHR Hip continues to perform very well in all registries and peer reviewed data sets.
What if I have additional questions?
Customers with questions regarding the BIRMINGHAM HIP Modular Head should contact their local sales management or sales representative. Also, additional information can be found in the field safety notice, linked to here.