In 2000, Sulzer Orthopedics noticed higher than normal revision surgeries on their InterOpAcetabular Shell. The shell was held to the pelvis with screws, yet these sockets started to loosen. Patients experienced persistent and sharp groin pain due to this loosening and were unable to bear their weight on the leg that had the implant. Approximately 25,000 shells were affected. 17,500 of these were already implanted in patients. Following weeks of investigation of patients record, surgical techniques, and the product itself, the company ordered a recall. Sulzer eventually agreed to $1 billion settlement with affected patients.
Category: Properties
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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