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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 designated the recall as Class II, a category the agency uses for products that have a low chance of causing serious injury or death, but still have a possibility of adverse events with irreversible consequences.
The implant had been on the market for more than 20 years, with a survivorship rate of 96.4% at 10 years, Zimmer spokesperson Heather Zoumas-Lubeski wrote in an email. She added that the company is “now supporting customers to transition to alternative Zimmer Biomet brands” as the system is phased out this year.
In a July letter to customers , Zimmer wrote that polished taper-slip (PTS) style stems are associated with a higher risk of postoperative periprosthetic femoral fracture (PFF) than other types of stems. Stems made from cobalt chromium alloy, like the CPT Hip System, also have an increased fracture risk compared to ones made of stainless steel.
If a fracture occurs, surgical intervention “will likely be required,” which involves fixing the fractured bone or replacing the femoral stem implant, the company wrote.
The recall letter cited an analysis by the MHRA. The regulator found that Zimmer’s hip implant system has a 1.4% risk of PFF in the U.K.
“While the risk of this fracture occurring is low, this is more than twice the risk of PFF compared to similar PTS stems that are not made of cobalt chromium,” the agency said in a Sept. 4 alert.
The MHRA determined a phase-out was appropriate due to the high number of U.K. hospitals using the implant.
In its recall notice, Zimmer said it would phase out sales of the device by December. The company instructed surgeons to “consider the benefits and risks” of using the CPT Hip System and inform patients of the increased fracture risk.
The FDA on Tuesday instructed surgeons to consider using an alternative prosthesis where possible, writing that the CPT Hip System should only be used when the benefits outweigh the risks and an alternative device is not available.
The FDA said it is working with Zimmer to ensure patients and healthcare providers are aware of the increased fracture risk and will work with international regulators to further evaluate device performance.