| TGA Action ID |
RC-2026-RN-00023-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Exactech Equinoxe Reverse Total Shoulder Arthroplasty System
Catalogue Numbers: 320-15-01, 320-15-02, 320-15-03, 320-15-04, 320-15-06, 320-15-07, 320-15-08, 300-01-07, 300-01-09, 300-01-11, 300-01-13, 300-01-15, 300-01-17 |
| ARTG Number |
244995, 262854, 284693, 284694, 284695 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Data from the AOANJRR demonstrate that male patients implanted with a standard size Equinoxe rTSA baseplate in combination with a press fit stem have higher rates of revision due to infection when compared to all Other Total Stemmed Reverse Shoulder systems.
AOANJRR data also demonstrate:
· The performance of the Equinoxe rTSA (all baseplates and all stems) in female patients is in line with all Other Total Stemmed Reverse Shoulder systems.
· The performance of the Equinoxe rTSA in male patients implanted with a small Equinoxe rTSA baseplate (all stems) and a standard Equinoxe rTSA baseplate (all stems other than press fit) is in line with all Other Total Stemmed Reverse Shoulder systems. |
| Instructions for Customers/Users |
When considering the use of standard sized Equinoxe glenospheres/glenoid baseplates combined with press fit stems in males, strict attention to aseptic surgical technique is recommended.
It is also recommended to:
• Consider this observation from the AOANJRR evaluating the patient preoperatively, when planning and executing the surgical procedure and scheduling appropriate patient follow-up visits.
• Provide additional advice and guidance to male patients, being implanted with standard sized Equinoxe glenospheres/glenoid baseplates combined with press fit stems, regarding the signs and symptoms to be aware of relating to postoperative periprosthetic joint infection.
· Normal patient follow-up, per each surgeon’s standard, is recommended for male patients who have been implanted with standard sized Equinoxe glenospheres/glenoid baseplates combined with press fit stems.
This action has been closed out on 10/09/2026 |
| Action Commencement Date |
30/01/2026 |
| Responsible Entity |
|
| Contact Information |
02 8882 9688 - Exactech |