MEDICAL DEVICES : problematic adhesion of PAH on femoral head

Faced with major strategic and regulatory challenges, the medical device sector is growing rapidly 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 items in specific environments, etc.: these are all daily issues for which the players in the medical device market must provide answers!

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

Used for many years to promote tissue repair and osseointegration, bio-active ceramics are now widely used in the medical device sector. Hydroxyapatite (or HAP) is one of the most sought-after ceramics when applied by projection as a coating on orthopaedic implants.

It is in this context that one of the main actors of PAH plasma spraying requested our laboratory to understand the origin of an adhesion defect of this type of coating on a metallic substrate revealed during production control tests.

The expertise proposed by our laboratory consisted first of all in characterizing from a morphological point of view by Field Effect Scanning Electron Microscopy (FEG-SEM) the decohesive 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 highlight the potential presence of surface pollution at this failure interface. The results made it possible to rule out a possible origin of the problem associated with the spraying process and to carry out specific actions upstream of this process which made it possible to eliminate the defect.

Thanks to the human skills and the complementary technical means available in our laboratory, FILAB was able to support this industrialist both from a technical point of view within the framework of the characterization of his defect and from a consulting point of view in order to solve his problem.

With significant experience in the implementation of these adhesion defect expertises, FILAB can assist you in the context of your problems associated with the medical device sector.

 

FILAB can also assist you with the following services: 

  • Biocompatibility studies according to ISO 10993 ( -18 / -12 / -13 / -14 / -15 / -19 / -22 )
  • R&D support: custom chemical analysis, material and surface characterization, analytical development
  • Problem solving: non-conformity, breakage, adhesion, corrosion…  
  • Process validation: Cleaning (ISO 19227), surface treatment

For more information, contact our expert: contact@filab.fr

Thank you !

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