Zimmer Biomet, a prominent medical device manufacturer, is set to discontinue sales of its CPT Hip System by December due to increasing concerns over the risk of thigh bone fractures, as stated by the Food and Drug Administration (FDA). These concerns were heightened earlier this month when the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) reported a heightened risk of thigh bone fracture post-surgery with the use of the CPT Hip System compared to other similar hip replacement devices. According to the MHRA, the analysis that identified this elevated risk remains unpublished. However, leading organizations such as the British Hip Society and the British Orthopaedic Association have already recommended limiting the use of this implant in elective surgeries except under exceptional conditions.
In response to these findings, Zimmer issued a recall in July for the CPT Hip System Femoral Stem 12/14 Neck Taper and updated the device’s instructions to reflect the associated fracture risks. The FDA categorized this recall as Class II, which is assigned to products that, while having a low chance of causing serious harm or death, nonetheless pose a risk of adverse effects that could have irreversible consequences. Notably, Zimmer has been marketing this implant for over two decades, during which it has recorded a survivorship rate of 96.4% at the 10-year mark, as conveyed by Zimmer spokesperson Heather Zoumas-Lubeski. She further mentioned that the company is aiding customers in transitioning to other Zimmer Biomet brands as the current system is being phased out.
In a July letter addressing its customers, Zimmer highlighted that polished taper-slip (PTS) style stems, like those used in the CPT Hip System, are linked with a higher risk of postoperative periprosthetic femoral fractures (PFF) compared to other types of stems. Additionally, it noted that stems manufactured from cobalt chromium alloy, which includes those in the CPT Hip System, present an increased fracture risk relative to those made from stainless steel. Should a fracture occur, surgical intervention is often necessary, potentially involving the repair of the fractured bone or the replacement of the femoral stem implant.
Zimmer’s decision to phase out the device followed a review by the MHRA, which found a 1.4% risk of PFF linked to the CPT Hip System within the UK—a risk that is more than double compared to similar PTS stems crafted from materials other than cobalt chromium. Given the widespread use of the implant across numerous UK hospitals, the MHRA deemed a phase-out appropriate.
Following this, Zimmer has advised medical professionals to weigh the benefits and risks of using the CPT Hip System and to make patients aware of the increased risk of fractures. The FDA has also urged surgeons to opt for alternative prostheses whenever possible, recommending the use of the CPT Hip System only in scenarios where its benefits decisively outweigh its risks and no suitable alternatives are available.
The FDA is currently collaborating with Zimmer to ensure that both patients and healthcare providers are sufficiently informed about the heightened fracture risk and is also cooperating with international regulators to conduct a more comprehensive evaluation of the device’s performance. This case highlights the critical need for ongoing monitoring and evaluation of medical devices in the market to ensure the safety and well-being of patients.
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