Field Safety Notice - Zimmer Biomet CPT® Hip System Femoral Stem 12/14 Neck Taper

Zimmer, Inc. is voluntarily initiating a medical device Field Safety Corrective Action (correction) for the CPT Hip System Femoral Stem 12/14 Neck Taper products listed in the Appendix 2 of the Notice due to an increased risk of postoperative periprosthetic femoral fracture (PFF).

While PFF is a generally recognized risk associated with all total hip arthroplasty, the current instructions for use (IFU) for the CPT Hip System Femoral Stem 12/14 Neck Taper do not identify post-operative bone fracture as a risk. As a result, Zimmer, Inc. is initiating a Field Safety Corrective Action to ensure that orthopaedic surgeons are aware of this risk and that the CPT Hip System Femoral Stem 12/14 Neck Taper displayed a rate of PFF at approximately 1.4% in the United Kingdom, which is more than twice the risk of PFF relative to a similar PTS reference product that is stainless steel. The IFU is in the process of being updated to reflect the risk of PFF, with an anticipated release by the end of August 2024.