The Therapeutic Goods Administration (TGA) of Australia has issued an alert concerning Articular Surface Replacement (ASR) XL total hip replacements, manufactured by Depuy.
The TGA advises consumers and health professionals that a recently published Australian study suggests a higher incidence of first hospitalisation due to heart failure among a group of male patients with ASR XL metal-on-metal (MoM) hip implants when compared with a similar group who had received a metal-on-polyethylene (MoP) implant.
The ASR XL is a type of MoM hip implant in which the two moving surfaces in the joint are both made of metal, whereas in MoP implants one of the surfaces is made of a plastic polymer. There is a growing body of evidence that because the two moving parts of a MoM hip implant wear against each other they can release trace amounts of cobalt and chromium (Co/Cr), especially during the first 18-months or so after the operation.
The latest study has several limitations and the authors found no evidence of a higher rate of heart failure in either female patients with ASR XL or in patients of either gender who had another type of MoM implant compared with patients who received MoP implants.
While the study reports that a higher proportion of male patients with ASR XL implants were hospitalised for heart failure after their hip replacements, there is nothing that reveals why this may be the case. More investigation will be needed to establish whether having an ASR XL implant causes a higher incidence of heart failure.
In the TGA alert, the corresponding information was given to consumers, health professionals and orthopaedic surgeons.
For details, please refer to the TGA website:
https://www.tga.gov.au/alert/asr-xl-total-hip-replacements
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 November 2016