| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01164-1 |
| Product Name/Description |
Active Knee System - Patella Insert (Used as a component in total knee replacement)
ASDM Part Number: 10-1514-075X
Lots manufactured prior to June 2012
ARTG Number:133900 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Advanced Surgical Design and Manufacture has become aware of elevated failure rates of the patella component of the Active Knee System, specifically related to the shearing of the pegs. Fourteen occurrences have been reported to date, which represents a failure rate of 0.7% of patellae implanted since July 2007. Batches which have been found to be affected were manufactured between 2007 and 2011, with failures presenting between 1 to 4 years after implantation.
Electron microscopy of the failed patella has shown that the patella pegs are failing due to fatigue. The initiation site for the fatigue failure appears to be a small overhang artefact, between 10 to 30 microns in depth, at the base of the patella peg. This small artefact may lead to elevated stresses at the base of the peg, and therefore increases the risk of premature product failure. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Advanced Surgical Design and Manufacture is advising implanting/treating surgeons on how to manage patients implanted with the affected Active Knee System. For more details, please see http://www.tga.gov.au/safety/alerts-device-active-knee-121205.htm This action has been closed-out on 12/04/2016. |
| Contact Information |
02 9439 4448 - Advanced Surgical Design and Manufacture |