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Introduction to Design Controls
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The DePuy ASR XL hip implant recall (2010) shows how gaps in design controls can lead to massive patient harm. Despite passing early testing, design verification, and post-market surveillance failed to catch issues like metal debris generation and tissue necrosis until thousands of patients were affected. Stronger design validation and better real-world monitoring could have prevented this.
It raises a tough question: can design controls ever truly predict every real-world failure, or are recalls like this inevitable in medical innovation?
Hip Recall Reference: https://en.wikipedia.org/wiki/2010_DePuy_Hip_Recall
Posted : 05/11/2025 9:40 pm
