You are likely aware of a recent communication within the surgeon community from Dr. Larry Dorr highlighting his experience with our Durom® Acetabular Component.
The purpose of this letter is to update you on actions ongoing at Zimmer in response to
complaints received about the Durom acetabular component.
Our foremost concern is that we provide safe and effective products available for use, and we take seriously all reports of this nature from our customers. In this instance, we have mobilized senior members of our Research, Development, and Quality teams to investigate the complaints. The results of the investigation will allow us to determine whether any corrective actions are necessary to ensure the ongoing safe and effective use of our products.
In this particular case, we are working with a number of experienced users of the Durom acetabular component to ensure that we have a full preview of the data and their experiences. We are also analyzing design history files and any other experience that we have. This obviously will take some time, but in the interim, we commit to inform you as soon as we make any significant conclusions from our investigation. Furthermore, if we determine that we need to take more aggressive action, we will do so.