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TGA recalls potentially defective replacement hips
The Therapeutics Goods Administration (TGA) today initiated a recall of zirconia ceramic femoral head hip replacement components manufactured by Saint Gobain CÉramiques AvancÉes Desmarquest in France following reports of serious failures with the product.
The company is the major manufacturer of zirconia implants in the world. The problem seems to be related to a change in the manufacturing process in 1998.
While there have been no reports of failures in hip replacements in Australia, overseas reports indicate that device failures of the affected batches have occurred 13 - 27 months post implantation, but long term studies are not yet available.
Femoral heads may be either metallic or ceramic. Ceramic implants are either Alumina or Zirconia. Zirconia implants are the most common of the ceramic implants.
Hip implants are modular in design, consisting of stem, femoral head, insert and cup. Hospitals maintain an inventory of both metallic and ceramic heads, and the surgeon makes the decision on which to use at the time of implant.
The recognised failure rate of these products is 1 in 10,000. The current reports indicate a failure rate as high as 8.8%.
Failure of the affected zirconia heads is sudden and without warning. There are no screening techniques to detect likelihood of failure. Once the component fails, total and immediate revision (re-operation and replacement) is required, with the patient immobilised until the revision can be performed.
Six sponsors within Australia supply Saint Gobain CÉramiques AvancÉes Desmarquest zirconia emoral head prostheses.
Since 1998 it is estimated that approximately 9,000 Australian patients have been implanted with a zirconia femoral head prosthesis.
Following consultation with the Therapeutic Device 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.
- 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 is a sudden change in their replaced hip.
The TGA urges recipients of hip replacement devices not to be overly alarmed but to contact their GP or orthopaedic surgeon.
Media contact: Kay McNiece 0412 132 585