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.
This Hazard Alert does not apply to either alumina ceramic or metallic femoral head prostheses. It also does not apply to zirconia femoral head prostheses manufactured by either Ceramtech or Morgan Matrock.
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.
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.
It is understood that Saint Gobain Céramiques Avancées Desmarquest manufactures approximately eighty percent (80%) of zirconia femoral head prostheses supplied worldwide.
Six (6) sponsors within Australia supply Saint Gobain Céramiques Avancées Desmarquest zirconia femoral head prostheses.
It has been estimated that approximately nine thousand (9,000) Australian patients may have been implanted with zirconia femoral head 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.gov.au).
Access to the TDEC Expert Orthopaedic Panel may be coordinated through the TGA on 02 6232 8683.
Sponsors:
- Biomet Australia P/L
- DePuy Australia P/L
- Smith & Nephew Surgical P/L
- Stryker Australia P/L
- Taylor Bryant P/L
- Zimmer Australia P/L