# China NMPA Product Recall - Birmingham hip joint modular ball head (femoral component)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-orthopedics-ltd/904dbcc3-b606-4766-aef6-900a523cbdb5/
Source feed: China

> China NMPA product recall for Birmingham hip joint modular ball head (femoral component) by Smith & Nephew Orthopedics Ltd. published October 11, 2012. Recall level: . Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., representing Smith & Nep

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is recalling its Birmingham hip replacement system.
- Company Name: Smith & Nephew Orthopedics Ltd.
- Publication Date: 2012-10-11
- Product Name: Birmingham hip joint modular ball head (femoral component)
- Recall Reason: According to the National Joint Registry for England and Wales, the overall revision rate for the Birmingham hip joint with various femoral stems is 1.29 per 100 prosthesis observation years (95% CI 1.11–1.49). In the Australian Society for Surgical Implants' National Joint Replacement Registry, the overall revision rate for the Birmingham hip joint with various prosthesis observation years is 1.12 per 100 prosthesis observation years (CI 0.93–1.34). These revision rates exceed the 1% revision rate benchmark set by the National Institute for Health and Care Excellence (NIH).
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Orthopedics Ltd.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., representing Smith & Nephew Orthopaedics Ltd., initiated a voluntary recall of its Birmingham Hip Replacement System (Modular Ball Head/Femoral Component). This recall, reported to China's National Medical Products Administration (NMPA) on October 11, 2012, was prompted by the product's overall revision rate exceeding established safety benchmarks. Global registry data from England, Wales, and Australia indicated revision rates of 1.29% and 1.12%, surpassing the 1% benchmark set by the UK's National Institute for Health and Care Excellence (NICE). Although no revision reports were received in China since the product's April 2011 introduction, the company proactively responded to the international performance data. Under NMPA oversight, corrective actions include notifying affected customers about proper product usage and updating the instruction manual for submission to China's State Food and Drug Administration. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is responsible for implementing these actions within China, with provincial authorities supervising the recall process.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-orthopedics-ltd/ce4ad0e9-49c1-433f-b695-a82625bda19a/