| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00525-1 |
| Product Name/Description |
HACTIV cementless femoral stems
Multiple reference numbers, sizes and UDIs
ARTG's: 232289 & 268272 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Based on 3 years of Australian registry data, the revision rate of the total hip prosthesis employing a HACTIV COLLARED cementless stem appears higher than expected. The 2022 figures of the Australian register were a THA revision rate/100 observation years of 1.95 and a cumulative percent revision rate of 4.6% at 4 years. For comparison, the figures for other total conventional hip replacements are 0.58 and 2.8% at 4 years.
The collared component is associated with a higher and earlier incidence of revisions due to infection, dislocation and instability. Infection and fracture are not typically related to the device and are more associated with external factors such as surgical technique, expertise, falls etc. However, dislocation/instability is possibly related to the implant (and potentially cup-step incompatibility). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are to be aware of the higher than anticipated revision rate when this stem is combined with acetabular cups from other manufacturers.
For patients implanted with a HACTIV femoral stem combined with components from a different manufacturer, the frequency of follow-up appointments should be at the discretion of the surgeon based on individual patient needs.
As per the Instructions for Use Evolutis implants must not be used with elements from any other manufacturer, as the components may not be compatible.
This action has been closed out on 24/07/2024 |
| Contact Information |
0488 240 471 - Jenny Burke, Evolutis |