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Cementless Columbus Knee System - used in knee replacements
Withdrawn from the ARTG
Health professionals and consumers are advised that B. Braun Australia, in consultation with the TGA, is withdrawing the cementless version of the Columbus Knee System from the Australian Register of Therapeutic Goods (ARTG). B. Braun Australia has also issued a related hazard alert to surgeons.
Columbus Knee Systems are used in total knee replacements. They can be implanted using bone cement for the fixation of the device, or without cement (cementless), and with or without resurfacing the kneecap (patella).
The decision to withdraw the cementless Columbus Knee System from the ARTG is based on an analysis of data collected by the Australian National Joint Replacement Registry (NJRR), which revealed that this device has a higher than anticipated revision rate.
Please note that only the cementless version of the Columbus Knee System is affected by this action.
Information for consumers
B. Braun Australia has contacted surgeons who have implanted the cementless Columbus Knee System, providing further information regarding the above issue and advice on how to treat affected patients.
If you have had a knee replacement and have any questions or concerns, please contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Patients who have had a knee replacement and who have any questions or concerns about the above issue should be referred to their surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
B. Braun Australia has contacted orthopaedic surgeons who have implanted the cementless Columbus Knee System, providing further information regarding the above issue and advice on how to treat affected patients.
Given the nature of the problem, there is no need to contact patients who have had a cementless Columbus Knee System implanted. However, it is recommended that orthopaedic surgeons conduct regular clinical and radiological examinations on those patients, in accordance with routine patient post-arthroplasty care, and advise them of this issue at that stage.
The TGA began monitoring the safety and performance of orthopaedic implants using data collected by the NJRR in 2006. The annual reports of the NJRR, and detailed information about implants that were identified as having higher than anticipated revision rates going back a number of years, are available on the NJRR website.
The NJRR first published information about a higher than anticipated revision rate for the Columbus Knee System in its 2009 annual report. This initiated a detailed investigation by both the TGA and the manufacturer, but at the time there was insufficient evidence to indicate the main reason for the higher revision rate.
The latest NJRR information, sourced in April 2013, indicates that the cementless Columbus Knee System has been used on 492 occasions and that 33 of those have been revised. The revision rate is 1.72 (95% CI: 1.19, 2.42) revisions per 100 observed years, which compares with a revision rate of 0.68 (95% CI: 0.67, 0.70) revisions per 100 observed years for all other total knee replacements.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.