The Prozyr Femoral Ball Recall

In 2001, in European and American regulatory agencies recalled millions of zirconia ball heads sold under the commercial name Prozyr by Saint Gobain Ceramiques Desmarquest. These heads are one of the important components used in a total hip replacement procedures also known as arthroplasty. This recall happened because the femoral ball heads were fracturing and failing at inordinately high rate after implantation in patients in a relatively short period of time. What followed was an intense international investigation by a panel of experts. The company and regulatory agencies wanted to find out answers to two central questions as soon as possible. What caused these fractures that led to the failure of these implants? What changed that caused this sudden jump in failure rates?

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The Map All Biomaterialists Should Understand

We know various material types (e.g., metals, ceramics, polymers) can be used as raw materials to develop an implant or device. We also know composites comprise of more materials. The manufacturing processes shape and assemble the materials into the final product. Heating and cooling techniques are routinely employed during the manufacturing process to shape and deposit the materials. These techniques generate microstructures (typically visible only under a microscope) that play an important role in defining the final product properties. During material’s thermal processing, understanding the nature of phase transformations that give rise to various microstructures is crucial for control of final product properties. Central to this understanding of phase transformation is to have a good grasp of phase diagrams or “maps” for the design of processing methods. So let us delve a little bit more into phase transformation and phase diagrams.

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