| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00223-1 |
| Product Name/Description |
LCS COMPLETE RPS Knee System
Model names: LCS COMPLETE RPS Femoral and the LCS COMPLETE RPS Insert
Multiple catalogue numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
JJM was recently notified by the Therapeutic Goods Administration (TGA), that the LCS COMPLETE RPS Knee System has a higher rate of revision than the class of PS knee systems based on recent data from the AOANJRR. After further analysis of the AOANJRR data, DePuy Orthopaedics, Inc (the manufacturer) determined that the LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. The need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Johnson & Johnson Medical is notifying surgeons of higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. Surgeons are advised that when using the LCS Complete RPS Knee System, the patella must be resurfaced. Johnson & Johnson Medical has also advised surgeons of the potential clinical implications for implanted LCS COMPLETE RPS Knee Systems where the native patella is not resurfaced.For further information https://www.tga.gov.au/alert/lcs-complete-rps-knee-system-used-knee-replacements. This action has been closed-out on 12/08/2016. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |