Smith & Nephew, Inc., Orthopaedic DIV.
FDA adverse event reports naming Smith & Nephew, Inc., Orthopaedic DIV. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV..
- Total reports
- 1,209
- Deaths
- 1
- Injuries
- 1,169
- Malfunctions
- 28
Reports per year
397
600
2601
4802
10103
31904
17605
12506
18007
19608
2809
110
Source: FDA adverse event reports by year received, 1997–2010. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH306
- Prosthesis, Knee, Hemi-, FemoralHSA285
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH86
- Nail, Fixation, BoneJDS73
- Plate, Fixation, BoneHRS62
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY59
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB55
- Screw, Fixation, BoneHWC34
- Orthopedic Manual Surgical InstrumentLXH30
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI27
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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