Medical Devices: HAP adhesion issues on femoral heads

Faced with major strategic and regulatory challenges, the medical device sector is experiencing strong growth in France and Europe. Ensuring the quality of finished products, verifying the biocompatibility of the materials used, optimizing your processes and cleaning procedures, testing the endurance and stability of your products in specific environments, …: these are just some of the everyday issues to which medical device market players must provide answers!

Nowadays, the materials used for medical devices are diverse: metal alloys (stainless steel, titanium, chrome-cobalt), organic materials (PEEK), ceramics, … Their success is largely based on their excellent mechanical, biocompatibility and corrosion-resistance properties.

Used for many years to promote tissue repair and osseointegration, bioactive ceramics are now widely used in the medical device sector. Applied by spraying as a coating on orthopedic implants, hydroxyapatite (or HAP) is one of the most widely used materials.

It was in this context that one of the leading HAP plasma-spraying companies contacted our laboratory to understand the cause of an adhesion defect affecting this type of coating on a metal substrate, revealed during production control testing.

The expertise provided by our laboratory initially involved morphologically characterizing, using Field Emission Scanning Electron Microscopy (FE-SEM), the delaminated surface between the coating and the substrate. Chemical analysis techniques such as X-ray Photoelectron Spectroscopy (XPS) and Secondary Ion Mass Spectrometry (SIMS) were then used to detect any potential surface contamination at the failure interface. The results ruled out a possible cause related to the spraying process and led to specific actions upstream of this process, which eliminated the defect.

Thanks to the complementary human expertise and technical resources available within our laboratory, FILAB was able to support this manufacturer both technically, by characterizing the defect, and through consulting services aimed at resolving the issue.

With significant experience in conducting investigations into adhesion defects, FILAB supports you with issues related to the medical device sector.