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 Matrock.

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 continue.

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 supplied worldwide.

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 since 1998.

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 (www.tga.health.gov.au).

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.

Aug 2001

 

Disclaimer: Note: The information described here relates solely to operational matters in the Emergency Department.  Every effort has been made to verify the accuracy of the content. However, neither the author or the hospital will take responsibility for errors resulting from its use.  Please refer to your own departmental guidelines and verify all clinical decisions with a reliable source.  

Date Last Reviewed: 05/08/2004