| TGA Action ID |
RC-2025-RN-00410-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FIXA Ti-Por Acetabular Cup
Multiple Product Descriptions
REF: 0753142, 0753144, 0753146, 0753148, 0753350, 0753352, 0753454, 0753456, 0753558, 0753560, 0753562, 0753564, 0753566 |
| ARTG Number |
207934 |
| Unique Device Identifier (UDI) |
FIXA Ti-Por Cup |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) has identified a higher than anticipated revision rate for the Fixa Ti-Por Cup. Further analysis has identified the cause to be linked to the use of non-sponsored metal head components in the total hip construct.
The higher-than-expected revision rate is seen within the first two years of implantation and presents as infection or early dislocation. |
| Instructions for Customers/Users |
Surgeons are warned to reconsider the use of total hip constructs that include the use of a non-sponsored metal head, with a non-sponsored stem and a Fixa Ti-POR Cup, due to higher-than-anticipated revision rates.
They should also schedule routine follow-ups with patients who have had this combination to assess for early signs and symptoms requiring revision surgery.
Patients are to be aware of symptoms such as new pain, inability to bear weight, or swelling, and follow up with a surgeon for further investigation.
This action has been closed out on 13/08/2025. |
| Action Commencement Date |
1/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 842 248 - Adler Ortho Australia |