Stain analyzes on orthopedic prostheses

Orthopedic prostheses are part of category 4 of medical devices, that is to say, dm presenting a high risk for the patient because they are fully implanted in the body and remain there for years or even life.
It is therefore essential that they comply with all the standards in force and that they do not present any defect or non-conformity, at the risk of not being able to be used.
It is with this problem that a client contacted us, in fact he is a manufacturer of orthopedic prostheses and he recently noticed the appearance of black spots on certain parts of their MD.

To understand where these tasks come from, it is essential to know their composition , which is why we carried out an analysis by electron microscopy in SEM / EDX .
This analysis revealed to us that these spots were composed of carbon and traces of aluminum .
Interesting information because following this revelation our client tells us about a suspect potential: the polishing paste , used during the manufacturing process.


Another investigation was therefore opened to find a correspondence between this polishing paste and the stains present on the MD.
As for the first analysis, the technical team carried out an analysis by electron microscopy, making it possible to highlight the presence of particles composed mainly of carbon and aluminum.
There is therefore a correlation between our non-compliant sample and this polishing paste!
Our client will henceforth change supplier for his polishing paste and if he still notices the presence of stains in his finished products our laboratory will be at his side to find the origin.
Do you encounter similar problems, want to understand the origin of a defect in order to rectify your production line? Contact us!

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