Institute of Good Manufacturing Practices India®

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Zimmer pulls hip implant off the market because of fracture risk

Zimmer Biomet plans to discontinue sales of its CPT Hip System by December due to concerns raised by the FDA regarding thigh bone fracture risks. The FDA remains worried about the system being used in new patients and is collaborating with the manufacturer to address these issues.

Recently, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) reported a higher incidence of thigh bone fractures post-surgery with the CPT Hip System compared to other hip replacement devices. Consequently, the British Hip Society and the British Orthopaedic Association recommended against its use for elective surgeries unless absolutely necessary.

In July, Zimmer recalled the CPT Hip System Femoral Stem, updating its instructions to highlight fracture risks. The FDA categorized the recall as Class II, indicating a low likelihood of severe injury but potential adverse effects. With a 96.4% survivorship rate over ten years, the implant has been on the market for over two decades. Zimmer advised surgeons to weigh the benefits and risks when considering the system for patients.