DePuy Orthopaedics (Johnson & Johnson)
DePuy ASR Hip Implant Recall
Estimated impact: $2.5B in settlements; 93,000 patients affected worldwide
J&J recalled the DePuy ASR metal-on-metal hip implant after failure rates reached 13% within 5 years. Internal documents showed J&J knew about elevated metal ion levels and high revision rates but delayed recall, settling 8,000+ lawsuits for $2.5B.
Decision context
Whether to recall the ASR hip system when internal data showed failure rates significantly above the industry average, or wait for more definitive evidence.
Decision anatomy
Red = risk factor present · Green = protective factor present
Biases present in the decision
★ Primary driver · Severity estimated from bias type and decision outcome
Toxic combinations
Reference class base rates
Across all 143 curated case studies in our library:
Lessons learned
- Loss aversion around a profitable product line delayed a recall that internal data warranted years earlier
- Selective perception in interpreting post-market surveillance data allowed J&J to dismiss adverse signals
- Metal-on-metal hip implants were adopted industry-wide based on theoretical advantages without adequate long-term human data
Source: FDA Class II Recall of DePuy ASR Hip System (2010); BMJ Investigation by Deborah Cohen (2011) (FDA Action)
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Workflows that fire on decisions like DePuy Orthopaedics (Johnson & Johnson)’s
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