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

MHRA 2022/006/008/593/003
NHSSC: 25

Alert:

  • 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.

Products Affected:

  • 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.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Please review the attached Surgical Technique Guide (STG) which has been updated to reflect this clarification (reference document number DSUS/JRC/0317/2044 Rev B).
  • Complete the customer reply form and return to MDFieldActionsUKIrl@its.jnj.com.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
  • Downloads ▼

    • 1714 Depuy Synthes Product Listing

      An Excel file detailing the product listing for ICN 1714.
      Login to view the downloads
    • 1714 Depuy Synthes Field Safety Notice

      A PDF file showing the Field Safety Notice for ICN 1714.
    • 1714 Depuy Synthes Cathcart Product Information

      A PDF file showing the product information for ICN 1714.