| TGA Action ID |
RC-2026-RN-00668-1 |
| Type of Product |
Biological |
| Product Name/Description |
Femoral Head (L) MC Allograft
Bone, frozen, irradiated
Allograft number 111833 |
| ARTG Number |
231769 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A previous donor to the living donor femoral head program, who upon assessment was determined to have been diagnosed with a breast cancer in 2021 approximately 4 years after their first femoral head donation back in 2017 (femoral head retrieved on 22 Mar 2017). The femoral head was transplanted into a recipient patient on 30 Nov 2021.
Although unlikely as the allograft does not contain live cells, there is a theoretical risk that the recipient may have received compromised tissue. The product was irradiated prior to supply.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). |
| Instructions for Customers/Users |
The TGA notes that at the time of retrieval for this donated bone, all Queensland Tissue Bank requirements were met and fulfilled and that the relevant surgeon has been notified of this problem in writing.
This action has been closed out on 09/09/2026 |
| Action Commencement Date |
7/09/2026 |
| Responsible Entity |
|
| Contact Information |
07 3121 2626 - Queensland Tissue Bank |