SMITH & NEPHEW ORTHOPAEDICS LTD

Manufacturer adverse-event records for SMITH & NEPHEW ORTHOPAEDICS LTD come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2009–2026 · thin-book · typical Death-code · injury-heavy

Injury-mix signature

SMITH & NEPHEW ORTHOPAEDICS LTD leans injury-heavy in event_type mix

Injury-coded event_type share is 98.2% (injury-heavy tercile) beside 0.27% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for SMITH & NEPHEW ORTHOPAEDICS LTD

The standout signal for SMITH & NEPHEW ORTHOPAEDICS LTD is Injury-mix: 98.2% Injury-coded (injury-heavy) beside 0.27% Death-coded, on a thin-book footprint.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 18 device types, led in this extract by Injury at 5,094 (98.2% of event_type total). Peak single-year volume reaches 588 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,190
Total Reports
14
Event-type Death
5,094
Injury Reports
18
Device Types

Event Types

Injury 5,094 (98.2%)
Malfunction 82 (1.6%)
Death 14 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Hospitalization 4,062 (41.1%)
R 4,061 (41.1%)
Required Intervention 637 (6.5%)
H 332 (3.4%)
O 277 (2.8%)
233 (2.4%)
Other 229 (2.3%)
S 15 (0.2%)
Death 12 (0.1%)
Life Threatening 7 (0.1%)
D 4 (0.0%)
L 2 (0.0%)
Disability 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

09
2009: 1
10
2010: 1
11
2011: 100
12
2012: 263
13
2013: 414
14
2014: 420
15
2015: 140
16
2016: 287
17
2017: 474
18
2018: 551
19
2019: 464
20
2020: 547
21
2021: 588
22
2022: 498
23
2023: 163
24
2024: 174
25
2025: 102
26
2026: 3