Medical device retrieval investigations

Implanted medical devices can fail, and when this happens, a thorough root cause failure investigation is needed.

Medical devices that are implanted for joint replacement or for reconstructive surgery can fail clinically.  There are many reasons an implant can fail – and certainly once the device has gone through the necessary regulatory process it is unlikely to be due to materials selection or the design of the device.  A root cause failure investigation is therefore critical to prevent future failures which may be a result of surgical technique or some design or materials element that has not yet been considered for the device, and which was not highlighted during biomechanical simulations, for example.

One Eighty provides a thorough root cause analysis of retrieved medical devices.  We have extensive experience in in vitro testing of sliding articulating devices and have in the past conducted these tests for many of the multinational medical device manufacturers in the USA and Europe.  We have two metallurgists and three advanced materials engineers who can apply their knowledge and ability to document the failed device and determine the mechanism for failure and therefore the root cause.  Furthermore, One Eighty is proud to have Rob Burns on our team. Rob has extensive clinical experience in a wide range of medical devices over the years and has assisted in varied surgeries across all fields of medical implants and procedures.

To find out more, contact One Eighty medical device expert Rob Burns on rob@one-eighty-degrees.com to discuss

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