Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19293 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0293] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

Advisory Committee; Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

forthcoming meeting of a public 

advisory committee of the Food and 

Drug Administration (FDA) to discuss 

current knowledge about the safety and 

effectiveness of Metal-on-Metal (MoM) 

hip arthroplasty systems. FDA is 

convening this committee to seek expert 

scientific and clinical opinion on the 

risks and benefits of these types of 

devices based on available scientific 

data. The meeting will be open to the 

public. 

DATES: The meeting will be held on June 

27 and 28, 2012, from 8 a.m. to 7 p.m. 

FDA is opening a docket to allow for 

public comments to be submitted to the 

Agency on the issues before the 

Orthopaedic and Rehabilitation Devices 

Panel of the Medical Devices Advisory 

Committee. Submit either electronic or 

written comments by May 9, 2012. 

ADDRESSES: Meeting location is to be 

determined (TBD). Prior to the meeting, 

FDA will announce the meeting location 

in a future Federal Register notice. We 

will also provide the meeting location 

on FDA’s Advisory Committee 

Information line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area) 

and on the Agency’s Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Avena Russell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1535, Silver Spring, 

MD 20993–0002, 301–796–3805, 

Avena.Russell@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

SUPPLEMENTARY INFORMATION: 

Name of Committee: Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Agenda: On June 27 and 28, 2012, the 

committee will discuss current 

knowledge about the safety and 

effectiveness of Metal-on-Metal (MoM) 

hip arthroplasty systems. FDA is 

convening this committee to seek expert 

scientific and clinical opinion on the 

risks and benefits of these types of 

devices based on available scientific 

data. 

Hip arthroplasty is intended to 

provide increased patient mobility and 

reduce pain by replacing the damaged 

hip joint articulation in patients where 

there is evidence of sufficient sound 

bone to seat and support the 

components. 

There are two categories of metal-onmetal hip arthroplasty systems: 

1. Metal-on-Metal total hip 

replacement (THR) systems consist of a 

metal ball (femoral head), a metal 

femoral stem in the thighbone, and a 

metal cup in the hip bone (acetabular 

component). MoM THR systems are 

typically indicated for use in total hip 

arthroplasty in skeletally mature 

patients with the following conditions: 

a. Non-inflammatory degenerative 

joint disease (NIDJD) such as 

osteoarthritis, avascular necrosis, posttraumatic arthritis, ankylosis, protrusio 

acetabuli, and painful hip dysplasia; 

b. Inflammatory degenerative joint 

disease such as rheumatoid arthritis; 

c. Correction of functional deformity; 

and, 

d. Revision procedures where other 

treatments or devices have failed. 

2. Metal-on-Metal hip resurfacing 

systems consist of a trimmed femoral 

head capped with a metal covering and 

a metal cup in the hip bone (acetabular 

component). Hip resurfacing 

arthroplasty is intended for reduction or 

relief of pain and/or improved hip 

function in skeletally mature patients 

having the following conditions: 

a. Non-inflammatory degenerative 

arthritis such as osteoarthritis, traumatic 

arthritis, avascular necrosis, or 

dysplasia/developmental dislocation of 

the hip (DDH); or 

b. Inflammatory arthritis such as 

rheumatoid arthritis. 

Resurfacing systems are intended for 

patients who, due to their relatively 

younger age or increased activity level, 

may not be suitable for traditional total 

hip arthroplasty due to an increased 

possibility of requiring ipsilateral hip 

joint revision. 

In February 2011, FDA published a 

Web site on MoM total and resurfacing 

hip systems with information for 

orthopedic surgeons and for patients 

with or considering hip replacement 

(http://www.fda.gov/MedicalDevices/ 

ProductsandMedicalProcedures/ 

ImplantsandProsthetics/MetalonMetal

HipImplants/default.htm). 

Numerous recent publications, 

studies and registry reports have raised 

safety concerns for MoM THRs. In 

February 2012, the United Kingdom’s 

(UK) Medicines and Healthcare 

products Regulatory Agency (MHRA) 

published a Medical Device Alert with 

updated advice on the management and 

monitoring of patients implanted with 

MoM hip systems recommending more 

aggressive followup of patients with 

larger THR systems (≥36 millimeter 

(mm)). Further information about 

actions taken by MHRA, with links to 

information about MoM hip implants 

for patients and healthcare 

professionals, is available on their Web 

site at http://www.mhra.gov.uk/Safety

information/Generalsafetyinformation

andadvice/Product-specificinformation

andadvice/Product-specificinformation

andadvice%E2%80%93M%E2%80%

93T/Metal-on-metalhipimplants/ 

index.htm. (FDA has verified the Web 

site address, but we are not responsible 

for any subsequent changes to the Web 

site after this document publishes in the 

Federal Register.) 

In December 2011, the American 

Academy of Orthopedic Surgeons 

(AAOS) published an overview on MoM 

hip systems (total and resurfacing) (Ref. 

1). The AAOS overview provides a 

summary of clinical outcomes in 

patients with MoM hip systems in 

comparison to other bearing surface 

combinations, addresses patient, 

implant and surgical factors that may 

predict successful/unsuccessful 

outcomes of MoM hip systems and 

discusses the prevalence of adverse 

clinical problems from MoM hip 

systems in comparison to other bearing 

surface combinations. One item 

referenced in the report is the 

Australian registry, which reported 

higher revision rates for patients with 

implants that have large-diameter heads 

(≥28 mm) (Ref. 2). 

While current data are highly 

suggestive that a large percentage of 

patients with MoM hip systems have 

successful outcomes, a recent scientific 

publication raised serious concerns 

about the failure rates of MoM hip 

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19294 Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 

systems for the UK population (Ref. 3). 

This peer-reviewed journal article 

presented the following findings 

regarding primary MoM THR: (1) 

Increased failure rate at 5 years for MoM 

THR related to larger head sizes; (2) 

significantly higher risk for revision in 

female patients (Note: In the United 

States, labeling discourages use of MoM 

hips in females of child bearing age with 

warnings in MoM THR labeling and 

contraindications in MoM hip 

resurfacing labeling); and (3) revisions 

for dislocation in men with MoM 

replacements were slightly lower, 

showing some benefit to larger head 

sizes. 

The committee will be asked to 

discuss the following as it pertains to 

these devices in the U.S. population: 

Device mechanisms of failure, metal ion 

testing, imaging methods, local and 

systemic complications, preoperative 

and postoperative patient risk factors, as 

well as clinical followup considerations 

for patients with MoM hip systems 

(total and resurfacing). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: FDA will work with 

affected industry, professional 

organizations, and societies that have an 

interest in the MoM hip arthroplasty 

systems and who wish to make a 

presentation separate from the general 

open public hearing; time slots on June 

28, 2012, between approximately 9 a.m. 

and 10 a.m. Representatives from 

industry, professional organizations and 

societies interested in making formal 

presentations to the committee should 

notify the contact person on or before 

May 1, 2012. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

May 9, 2012. On June 27, 2012 oral 

presentations from the public will be 

scheduled between approximately 9 

a.m. and 10 a.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 1, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 2, 2012. 

Comments: FDA is opening a docket 

to allow for public comments to be 

submitted to the Agency on the issues 

before the Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices Advisory Committee 

beginning on March 30, 2012, and 

closing on May 9, 2012. Interested 

persons are encouraged to use the 

docket to submit electronic or written 

comments regarding this meeting. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Divisions 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact James Clark, 

James.Clark@fda.hhs.gov or 301–796– 

5293 at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

I. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see Comments) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. American Academy of Orthopedic 

Surgeons, ‘‘Modern Metal-on-Metal Hip 

Implants: A Technology Overview’’ (July 

15, 2011), accessed online at http:// 

www.aaos.org/research/overviews/ 

Metal_On_Metal.pdf. 

2. Adelaide: Australian Orthopaedic 

Association, Australian Orthopaedic 

Association National Joint Replacement 

Registry: Annual Report 2010, 2010. 

3. Smith, A.J., P. Dieppe, K. Vernon, et al., 

‘‘Failure Rates of Stemmed Metal-onMetal Hip Replacements: Analysis of 

Data From the National Joint Registry of 

England and Wales,’’ Lancet (March 13, 

2012), accessed online at http:// 

www.thelancet.com/journals/lancet/ 

article/PIIS0140–6736(12)60353-5/ 

fulltext#article_upsell (doi:10.1016/ 

S0140–6736(12)60353–5). 

Dated: March 27, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7767 Filed 3–29–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: May 7, 2012, 8:30 a.m. 

to 5 p.m., May 8, 2012, 8:30 a.m. to 5 p.m. 

Place: Westin Denver Downtown Hotel, 

1672 Lawrence Street, Denver, Colorado 

80202. Telephone: (303) 572–9100. 

Fax: (303) 572–7288. 

Status: The meeting will be open to the 

public. 

Purpose: The purpose of the meeting is to 

discuss services and issues related to the 

health of migrant and seasonal farmworkers 

and their families and to formulate 

recommendations for the Secretary of Health 

and Human Services. 

Agenda: The agenda includes an overview 

of the National Advisory Council on Migrant 

Health’s (The Council) general business 

activities. The Council will also hear 

presentations from experts on farmworker 

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