| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01395-1 |
| Product Name/Description |
Active Knee Total Knee Replacement System
Active Knee (Cemented) Femoral Component
Catalogue # 10-1521-0342 to 10-1522-0270, 10-1513-0500 to 10-1513-0509
ARTG # 217122, 217127
Active Knee (Cementless) Tibial Component
Catalogue #10-1521-0302 to 10-1522-0230, 10-1513-0400 to10-1513-0409
ARTG # 133900, 217128
Active Knee Patella
Catalogue # 10-1514-0750 to 10-1514-0754
ARTG # 217306
Active Knee Knee Insert/Bearing
Catalogue # 10-1533-0080 to 10-1533-0275
ARTG # 217305, 217297 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Review of the Australian Orthopaedics Association's National Joint Replacement Registry (AOANJRR) data shows that the Active Femoral Component used with (cemented or cementless) Active Knee Tibial Component has a higher revision rate than expected when compared to similar implants. A large number of the revisions were due to patella breakage. Further analysis of the information held by AOANJRR indicates that use of the Active Knee Total Knee Replacement Prosthesis without patella resurfacing at the time of primary surgery may lead to increased risk of patella erosion and patella-femoral pain. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The following advice is provided to surgeons who have used Active Total Knee Replacements to ensure continued safe use and proper patient management.
For prospective patients:
- It is strongly recommended that patella resurfacing is performed when the Active Total Knee replacement femoral components are used.
- Use of the Active Femoral Component otherwise may proceed as normal.
For patients who have received the Active Femoral Component without patella resurfacing:
- Asymptomatic patients do not require surgical intervention as a result of this alert.
- Particular consideration for the increased risk of patella erosion and patella-femoral pain will need to be paid to patients at follow-up visits.
- The surgeon may consider more careful or frequent follow-up.
This action has been closed out on the 01/11/2018. |
| Contact Information |
1800 644 370 - Allegra Orthopaedics |