Medical device company DePuy (a Johnson & Johnson company) in July voluntarily recalled a prosthesis known as the LCS Duofix Femoral Component because one material used affected the tissue in the joint.
The knees were recalled after the problem was detected. Fewer than 1000 South Australians are believed to have had them put in, and up to 10 had to have them taken out again.
The company refused to release specific figures because of “commercial sensitivity”. A field safety notice issued by DePuy says the Australian revision rate this year was 1.45 per cent, although globally it was 0.57 per cent.
“A subset of these revision patients presented within three years of implantation with symptoms of pain and swelling,” it says. “Third body wear and/or tissue staining were found upon investigation.”
DePuy admits it does not understand all factors contributing to the revisions and says it will set up an independent medical review team.
Johnson & Johnson Medical communications director Michelle Lawlor said less than 1 per cent of implants in South Australia since 2005 had been revised.