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
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.