Fed: Artificial hips recalled

AAP General News (Australia)
08-17-2001
Fed: Artificial hips recalled

CANBERRA, Aug 17 AAP - Artificial hips should be chosen on quality rather than cost
after one brand was found to be at risk of disintegrating, Australian Medical Association
(AMA) president Kerryn Phelps said today.

The Therapeutic Goods Administration (TGA) last night announced a recall of parts of
the widely used French-made product, which has a failure rate overseas as high as 8.8
per cent.

The Zirconia brand ceramic hip has been reported to spontaneously disintegrate in some cases.

While there had not been any reports of failures in hip replacements in Australia,
overseas reports indicated failures of the affected batches had occurred 13 to 27 months
after implantation, the TGA said.

Dr Phelps said the failure of the hip replacements was frightening for patients.

"Not only is the cost of hip replacement high but people quite often have to wait for
years in pain to get the operation and to then find out that it may fail in 13 to 18 months
is rather frightening," she said.

She advised people with hip replacements to seek advice from their orthopaedic surgeon.

She also warned the quality of products being used needed to be monitored.

"We need to, as a community, look at the quality of the products that are being provided
to Australian patients and to make sure that we are not going for the cheapest model but
that we are going for models that are going to last the distance," she said.

The TGA said failure of the affected zirconia heads was sudden and unheralded.

"There are no screening techniques to detect likelihood of failure," it said in a statement.

"Once the component fails, total and immediate revision (re-operation and replacement)
is required, with the patient immobilised until the revision can be performed."

About 9,000 Australian patients have been fitted with the faulty part and the TGA has
ordered a recall of all stock parts and the monitoring of patients with the part.

The authority advised against replacement of the part if it was not broken.

Signs that the part was breaking includes sudden inability to walk, sudden hip pain
and a sudden jolt in the hip.

AAP eg/kjp/mg/bwl

KEYWORD: HIP

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