Important Information On Spontaneous Rupture Of
Zirconia Femoral Head Prostheses
The Therapeutic Goods Administration, in consultation with sponsors of
orthopaedic prostheses, is coordinating the distribution of a Hazard Alert relating to all
Saint Gobain Céramiques Avancées Desmarquest zirconia femoral head prostheses.
Ceramic femoral head prostheses were first introduced into Australia
for use in hip arthroplasty approximately fifteen (15) years ago. Prior to that, metallic
femoral head prostheses were used.
Ceramic femoral heads are one component of a hip prostheses and are
either composed of alumina or zirconia. We believe these zirconia components are
manufactured by three different manufacturers world wide the Hazard Alert does NOT
apply to zirconia femoral head prostheses manufactured by either Ceramtech or Morgan
Further, the Hazard Alert does not apply to either alumina ceramic or
metallic femoral head prostheses.
The TGA has been notified of spontaneous disintegration of zirconia
femoral head prostheses in some batches manufactured by Saint Gobain Céramiques Avancées
Desmarquest. The problem seems to be related to a change in the manufacturing process in
1998. The spontaneous disintegration of zirconia femoral head prostheses is reported to be
occurring between thirteen (13) and twenty-seven (27) months after implantation. The
number of batches affected and the exact cause of these spontaneous disintegrations remain
uncertain at this point in time. More information will become available as investigations
Spontaneous disintegration of these zirconia femoral head prostheses
has been reported in Canada, Europe, and the United States of America. Spontaneous
disintegration has been reported in up to 8.8% of these zirconia femoral head prostheses
in one batch.
It is understood that Saint Gobain Céramiques Avancées Desmarquest
manufactures approximately eighty percent (80%) of zirconia femoral head prostheses
Six (6) sponsors in Australia supply Saint Gobain Céramiques Avancées
Desmarquest zirconia femoral head prostheses and it has been estimated that approximately
nine thousand (9,000) Australian patients may have been implanted with these prostheses
Following consultation with a Therapeutic Devices Evaluation Committee (TDEC) Expert
Orthopaedic Panel, the TGA has:
- Recommended immediate recall of all
unimplanted zirconia femoral head prostheses manufactured by Saint Gobain Céramiques
Avancées Desmarquest. Individual sponsors are coordinating the identification of
prostheses manufactured by Saint Gobain Céramiques Avancées Desmarquest.
- Recommended orthopaedic surgeons inform
all patients implanted with a Saint Gobain Céramiques Avancées Desmarquest zirconia
femoral head prosthesis that they should seek urgent medical attention should they be
concerned that there has been a sudden change in their replaced hip.
- That knowledge of any problems that
occur, or have occurred, at any time with any zirconia femoral head prostheses be reported
to the Device Incident Report Scheme on (02) 6232 8713. An Incident Report
Investigation Scheme (IRIS) report form can be accessed on the TGA website
Expert clinical advice indicates that the femoral head disintegrates
suddenly and without warning. This causes an immediate local tissue reaction, which
requires urgent medical intervention to prevent further complications.
If your patient has experienced any of the following:
- A sudden inability to walk; and/or
- A sudden pain in the hip; and/or
- A sudden jolt in the hip that has been operated on,
It may suggest your patient has experienced a spontaneous rupture of their zirconia
femoral head prosthesis. In this event, seek urgent specialist orthopaedic consultation.
Sponsor Contact Officers:
- Biomet Australia P/L David le Cheminant 02 9878 6100
- DePuy Australia P/L Peter Witherspoon 03 9562 6166
- Smith & Nephew Surgical P/L Lindsey Anderson 02 9857 3999
- Stryker Australia P/L George Faithfull 02 9415 5100
- Taylor Bryant P/L John Markarian 02 9906 8355
- Zimmer Australia P/L Michael Schaffler 02 9950 5400
NOTE: For updated information in relation to this recall please see
the TGA website at www.health.gov.au/tga
or contact 1800 447 394.