Zimmer Biomet is issuing a Field Safety Corrective Action for the CPT@ Hip System Femoral Stem 12/14 Neck Taper due to an increased risk of postoperative periprosthetic femoral fracture (PFF).
Risks:
In the event of PFF, surgical intervention will likely be required. Consider potential risk factors for PFF, such as increasing age, intra-operative fracture, increasing stem offset, increasing head size, and low viscosity bone cement.
Product Phase Out:
Zimmer Biomet has decided to phase out the CPT@ Hip System Femoral Stem 12/14 Neck Taper, with a target of December 2024 to stop sales in the market.
Surgeon Responsibilities:
Review this Field Safety Notice for awareness of the contents. 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.
Zimmer Biomet is updating the IFU to reflect the risk of PFF. The latest IFU can be viewed electronically at labeling.zimmerbiomet.com.
Manual:
Download: ZIMER BIOMET CPT@ Hip System Femoral Stem 12/14 Neck Taper Field Safety Corrective Action Manual
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