URGENT MEDICAL DEVICE FIELD SAFETY NOTICE (CORRECTION) INCREASED RISK OF PERIPROSTHETIC FEMORAL FRACTURE – CPT@ Hip System Femoral Stem 12/14 Neck Taper

Field Safety Corrective Action

Zimmer Biomet is voluntarily initiating a medical device 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).

The CPT@ Hip System Femoral Stem 12/14 Neck Taper is a polished taper-slip (PTS) style stem manufactured from cobalt chromium alloy, which is associated with an increased risk of PFF compared to composite beam stems.

Risks and Actions

In the event of PFF, surgical intervention will likely be required. Users should consider potential risk factors for PFF, such as increasing age, intra-operative fracture, and low viscosity bone cement.

Zimmer Biomet is phasing out the CPT@ Hip System Femoral Stem 12/14 Neck Taper, with a target of December 2024 to stop sales. The company will provide dedicated training opportunities and adjust supply plans to aid surgeons in transitioning to new hip stem brands.

Hospitals and surgeons are responsible for reviewing this Field Safety Notice, ensuring affected personnel are aware of the contents, and coordinating with local Zimmer Biomet representatives on a transition plan.

Manual:

Download: URGENT MEDICAL DEVICE FIELD SAFETY NOTICE (CORRECTION) INCREASED RISK OF PERIPROSTHETIC FEMORAL FRACTURE – CPT@ Hip System Femoral Stem 12/14 Neck Taper

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