CPT® Hip System Femoral Stem 12/14 Neck Taper – Increased risk of post-operative Periprosthetic Femoral Fracture (PFF)

A Dear Healthcare Professional Letter has been issued by Zimmer Biomet to inform healthcare professionals about an increased risk of post-operative periprosthetic femoral fracture (PFF) associated with the CPT^® Hip System Femoral Stem 12/14 Neck Taper. The CPT^® Hip System Femoral Stem 12/14 Neck Taper is a polished taper-slip (PTS) style stem manufactured from cobalt chromium alloy. Registry-based analyses have indicated that all PTS stems are associated with increased risk of PFF compared to composite beam stems, especially those manufactured from cobalt chromium alloy in comparison to stainless steel. In the event that PFF occurs, which is often associated with a traumatic event, surgical intervention will likely be required. Zimmer Biomet will be updating the IFU to reflect the risk of PFF. Healthcare professionals are advised to consider the benefits and risks of implanting the CPT^® Hip System Femoral Stem 12/14 Neck Taper on an individual patient basis and ensure patients are informed appropriately on the increased risk of PFF. There are no specific patient monitoring instructions that are recommended beyond the existing patient follow-up schedule. Please refer to the letter for details.

Published: 22 Jul 2024

Dear Healthcare Professional Letters