| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00883-1 |
| Product Name/Description |
ADVANCE HA Coated TitaniumTibial Bases, all sizes
Part Numbers: KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, KTTIHA50, KTTIHA51, KTTIHA60
All Lots |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
In October 2015, the AOAJNRR annual report indicated that the implant was experiencing higher than expected revision rates of 1.37 revisions per 100 observed years. The cumulative percent revision of the implant at 10 years is 11.8% compared to 5.5% for other knee implants. Further analysis showed that a large proportion of the revisions (46.9% of revisions, 2.3% of primary procedures) were due to loosening/lysis, and that the ADVANCE HA Coated Tibial Base was contributing to the higher rate and therefore Microport has decided to remove this device from the market. ADVANCE HA Coated Tibial Bases have not been used in Australia since 2013 and have been withdrawn from the Australian Register of Therapeutic Goods (ARTG). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
MicroPort Orthopaedics Pty Ltd is contacting surgeons to make them aware of this issue with the advice that the likelihood of a patient experiencing a postoperative loosening is very low. Should a patient experience sudden pain, instability, difficulty walking and/or performing common tasks, a tibial loosening can be confirmed via x-ray. A loosened tibial base may require removal through revision surgery. For more details, please see https://www.tga.gov.au/alert/advance-ha-coated-tibial-bases . This action has been closed-out on 24/05/2017. |
| Contact Information |
1300 665 884 - Surgical Specialties |