Zimmer pulls hip implant off the market due to fracture risk (MedTechDive)The company plans to phase out use of its CPT Hip System by December, but the FDA is still concerned about implants in new patients.
Dive Brief:
Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice.
Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.”
Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.
Dive Insight:
Zimmer recalled its CPT Hip System Femoral Stem 12/14 Neck Taper in July, updating the device’s instructions for use to reflect the fracture risk.
The FDA desig...
