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Background
The Therapeutic Goods Administration (TGA) has received enquiries about the recall of the LCS® DuofixTM Femoral Knee Replacement Component. The information below is provided for consumers about the recall and the TGA's regulatory activities in relation to that product.
Why the LCS® DuofixTM Femoral Component was recalled
On 24 July 2009, the TGA approved a recall of the LCS® DuofixTM Femoral Knee Replacement Component. This was in response to an increasing, but still low, number of patients needing to have the implant replaced.
The TGA became aware of the issue in July 2009 following hospitals and surgeons notifying the Australian sponsor, Johnson & Johnson Medical Pty Ltd, of problems with the implant. In keeping with the TGA's post-market monitoring protocols, the sponsor advised the TGA of the problem.
DePuy International Ltd (the UK manufacturer of the LCS® DuofixTM Femoral Knee Replacement Component) conducted an investigation and has stated in its patient information statement sent to surgeons that "microscopic particles of a substance used in the manufacturing process may sometimes enter the area surrounding the implant. While the particles do not react with the body, they may potentially cause increased wear of the implant and subsequent symptoms of pain and swelling. These symptoms usually occur within three years of surgery."
About the 2009 recall
Johnson & Johnson recalled all batches of the LCS® DuofixTM Knee Replacement Femoral Component and voluntarily ceased supply of the product in Australia at the same time. The product was subsequently cancelled from the Australian Register of Therapeutic Goods on 13 January 2010 which means it is no longer available in Australia. Surgeons and the Australian Orthopaedic Association were notified of these actions so that they could respond to patients' enquiries.
Information for patients
The TGA has received 125 adverse event reports for the LCS® DuofixTM Femoral Knee Replacement Component, approximately 70% of which were received after the recall. If you experience ongoing and unexplained symptoms of pain and swelling around the knee joint, or have any additional questions regarding this matter, please contact the surgeon who performed your knee replacement surgery to obtain medical guidance. Your surgeon knows your medical history and is in the best position to advise you regarding your personal situation.
About the Therapeutic Goods Administration (TGA)
- The TGA is part of the Australian Government Department of Health and Ageing and is responsible for regulating medicines and medical devices.
- TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports it receives to determine whether any regulatory action is required.
- To report a problem with a medicine or medical device, please see information on the TGA website.
How the TGA monitors repeat surgery
- The TGA monitors the repeat surgery (revision) histories of orthopaedic implants by reference to the National Joint Replacement Registry (NJRR) and its own adverse event data.
- The NJRR annual report for 2010 released on 1 October 2010 (covering the 2009 calendar year) contains the following statement:
The Registry has undertaken an analysis of the LCS Duofix femoral prosthesis, which was recalled in 2009. The Registry had recorded 4,862 procedures using this prosthesis up to and including 31 December 2009. It has a higher revision rate compared to all other primary total knee replacements (adj HR=1.20; 95%CI(1.00, 1,44), p=0.046).