China NMPA Product Recall - Hip joint surface replacement system

This document, an NMPA Medical Device Recall Event Report Form, details a voluntary recall initiated by DePuy International, Ltd, with its Chinese responsible unit being Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The report, dated August 24, 2010, and published on August 31, 2010, concerns their Hip Joint Resurfacing System, specifically the ASR™ Acid Resurfacing System and ASR™ XL Metal-to-Metal Full-Ground System. The primary issue prompting the recall is new data from the National Joint Registry (NJR) in England and Wales. This data revealed a higher-than-expected five-year revision rate for these hip systems: approximately 12% for the ASR™ Acid Resurfacing System and 13% for the ASR™ XL Metal-to-Metal Full-Ground System. A particular concern was identified for female patients receiving ASR femoral head prostheses with a diameter less than 50 mm, who faced the highest risk of revision. Operating under the oversight of the National Medical Products Administration (NMPA) in China, DePuy decided to execute a global voluntary recall for all affected ASR/ASR products. The required actions included notifying all users of the DePuy Hip Replacement System and managing the recall of 12,166 affected units imported into China, of which 11,522 had been sold. This swift action aims to address the safety concerns highlighted by the updated performance data.