| May 21, 1997 |
Dear Colleague:
This is to inform you that
steam sterilization has been associated with surface roughening
of zirconia ceramic femoral head components of total hip prostheses.1
This occurs because exposure to steam and elevated temperatures
may lead to a phase transformation in the crystal structure of
the zirconia material. As a consequence of this roughening, increased
wear on the ultra-high molecular weight polyethylene acetabular
component may occur, which can cause premature failure and require
early revision.
Because of the damage steam
sterilization can cause, manufacturers of hip prostheses with
zirconia femoral heads sterilize them using ethylene oxide. If
these devices require re-sterilization because the package has
been damaged or opened, we caution against using steam sterilization.
The manufacturer should be contacted for further instructions.
If a clinician observes unusual
damage or premature failure of a hip prosthesis with a zirconia
ceramic femoral head, he or she should report this to FDA under
the Safe Medical Devices Act of 1990 (SMDA), which requires hospitals
and other user facilities to report deaths and serious illnesses
and injuries associated with the use of medical devices. Practitioners
should follow the procedures established by their facility for
such mandatory reporting.
For problems and/or malfunctions,
not required to be reported under SMDA, we encourage you to report
directly to MedWatch, the FDA's voluntary reporting program, by
phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail
to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2),
Rockville, MD 20857.
Should you have questions about any of the matters discussed in this letter, please contact Gary Fischman, CDRH, Office of Science and Technology, HFZ-150, 12200 Wilkins Avenue, Rockville, MD 20852, or FAX 301-443-5259.
| Sincerely yours, D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health |
1 U.K. Medical Devices Agency, Adverse Incidents Centre. Safety Notice MDA SN 9617, "Zirconia Ceramic Heads for Modular Total Hip Femoral Components: Advice to Users on Re-Sterilization".
Updated June 5, 1997
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