Field Safety Notice DePuy Synthes Modular Cathcart Unipolar Head Multiple Products (ICN 1714)
Important Customer Notice Field Safety Notice
Ref: 2022/1714 ICN Number: 1714
- DePuy Orthopaedics, Inc. (Warsaw, IN) is initiating a field safety notice (FSN) for all lots of the Modular Cathcart Unipolar Head (Cathcart Head).
- The Cathcart Head includes a +5mm offset, which was not specified in previous versions of the SELF-CENTERING™ Bipolar and Modular Cathcart Unipolar Endo Heads Surgical Technique Guide (STG).
- This +5mm offset should be taken into consideration when using a Cathcart head in a construct for hip arthroplasty procedures.
- Patients implanted with the Cathcart Head in a construct that exceeds the overall suggested total offset may experience implant (stem) fracture, pain, loosening, dislocation, poor joint mechanics, post-op bone fracture-major.
- There are 17 affected products that are available from NHS Supply Chain eDirect route.
- Please see our Downloads section for the product listing and Field Safety Notice for further information on the affected product.