| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00497-1 |
| Product Name/Description |
Acor and Integrale primary femoral stem with modular neck
Reference Numbers: 1-0106701, 1-0106702, 1-0106703, 1-0106704, 1-0191001, 1-0191002, 1-0191003 and 1-0191004
Certificate Number: DV-2013-MC-04752-1
ARTG Number: 210537 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Amplitude would like to emphasize that patient selection is a key factor for the primary or revision implantation of the Acor and Integrale primary femoral stem with modular neck systems. Patients with both a large lever arm and a heavy weight often cause severe stress on the modular joint.
Reports of femoral neck fractures for certain combinations of modular necks and femoral heads have been received by the manufacturer, Amplitude. Subsequently, additional mechanical tests determining the fatigue strength of the proximal stem geometry have been conducted on the modular neck stems according to the recent standard ISO 7206 -6: 2013 in order to determine which combinations of necks and heads should be subjected to usage restrictions.
The surgical technique and the IFU have been updated with these usage restrictions regarding combination bans and admissible patient weight limits. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Neosurgical is updating the IFU and Surgical Technique to highlight to surgeons the importance of observing the head/neck combination restrictions when using the device. Users are also advised to report any adverse reactions observed with the devices to Amplitude and/or to the Therapeutic Goods Administration (TGA).
This action has been closed out on 14/11/2018 |
| Contact Information |
02 8015 7914 - Neosurgical |