Smith & Nephew Orthopaedics Ltd
FDA adverse event reports naming Smith & Nephew Orthopaedics Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITH & NEPHEW ORTHOPAEDICS LTD.
- Total reports
- 5,211
- Deaths
- 14
- Injuries
- 5,112
- Malfunctions
- 85
Reports per year
26312
41413
42014
14015
28716
47417
55118
46419
54720
58821
49822
16323
17424
10225
2426
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingNXT4,881
- Prosthesis, Hip, Hemi-, Femoral, MetalKWL173
- Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/PolyacetalJDH47
- Prosthesis, Hip, Femoral, ResurfacingKXA19
- Prosthesis, Hip, Femoral Component, Cemented, MetalJDG18
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY18
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH12
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousMBL10
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI9
- Orthopedic Manual Surgical InstrumentLXH5
Recent recalls
- TerminatedComponent change control
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
The nail head may become detached during surgery.
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