Consumers and health professionals are advised that Johnson & Johnson Medical has withdrawn an application to transition the LCS Complete RPS cemented femoral component from Class IIb to Class III.
As a result of this, the component is no longer included on the Australian Register of Therapeutic Goods and cannot be used in Australia.
Hazard alert – higher than expected revision rate when used without patella resurfacing
31 March 2015
Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, has issued a hazard alert regarding its LCS Complete RPS Knee System due to a higher than expected revision rate when the patella is not resurfaced.
Knee implants can be used in a variety of configurations. One option is to use a 'button' to 'resurface' the back of the patient's patella and keep it from potentially rubbing against the implant as the knee bends.
An additional analysis of data derived from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 2014 Report shows that the revision rate for the LCS Complete RPS Knee System when used without a patella button is higher than the revision rate of other unresurfaced posterior-stabilised (PS) knee implants being used in Australia.
It is recommended that surgeons always resurface the patella when implanting LCS Complete RPS Knee System.
Information for consumers
Johnson & Johnson Medical has contacted surgeons who have used the LCS Complete RPS Knee System advising them of the issues outlined above.
If you have had a knee replacement and experience pain, or if you 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
Johnson & Johnson Medical (as a sponsor of DePuy International devices in Australia) has contacted surgeons who have used the LCS Complete RPS Knee System providing further information about this issue.
Surgeons have been advised to always resurface the patella when implanting LCS Complete RPS Knee System.
Prophylactic revision in the absence of symptoms is not recommended. Surgeons should discuss potential clinical implications and risks with symptomatic patients that received the LCS Complete RPS Knee System with an unresurfaced patella.
Additional information
| Model | Patella usage | 1 year | 2 years | 3 years | 4 years |
|---|---|---|---|---|---|
| LCS PS | Patella used | 0.3 (0.0, 2.2) | 1.4 (0.5, 3.7) | 2.4 (1.1, 5.4) | 3.3 (1.5, 7.1) |
| No patella | 3.6 (2.0, 6.5) | 9.7 (6.9, 13.7) | 11.5 (8.3, 15.7) | 12.9 (9.6, 17.4) | |
| Other PS total knee | Patella used | 0.9 (0.8, 0.9) | 1.6 (1.6, 1.7) | 2.2 (2.1, 2.2) | 2.6 (2.5, 2.7) |
| No patella | 1.1 (1.1, 1.2) | 2.3 (2.3, 2.4) | 3.1 (3.0, 3.2) | 3.6 (3.6, 3.7) |
The above data comes from an AOANJRR analysis of the revision rate of 330 resurfaced and 305 unresurfaced LCS Complete RPS Knees, compared with the rate among all other total knee transplants. When the patella was resurfaced the cumulative revision rates were not significantly different when compared to all other resurfaced implants.
Reporting problems
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.