Every new orthopaedic implant sold or launched by Zimmer is subject to a strictly regulated product development and approval procedure. Prototypes and market-ready implants undergo comprehensive testing, including laboratory tests, before they are launched on the market.
All of this testing complies with internationally recognised standards and guidelines as well as with test protocols that were agreed upon between the manufacturers and regulatory authorities.
The chapters below provide more information about the following topics.
Today, hip arthroplasty is already at a high standard. Companies are researching new solutions with the goal of continuously extending the life of the artificial joints.
Every year around 193,000 hip stems, 145,000 hip cups and 195,000 ball heads are manufactured for the world market at Zimmer‘s Winterthur site (Switzerland). Added to this are products for the knee and shoulder joints, spinal implants and implants for trauma care.
Seven out of 19 manufacturing steps for a standard Zimmer hip stem are quality assurance steps, and every sixth Zimmer employee at the European headquarter works in the quality and quality assurance areas.
The approval process for orthopaedic implants is very strict and entails several steps. Medical devices are only approved for the market if they were subjected to a so-called conformity assessment procedure. Within the scope of this assessment, manufacturers must prove the safety of their products and their medical-technological effectiveness in regard to their respective area of application. This verification procedure is designated as a clinical assessment.