SMITH & NEPHEW, INC.

Manufacturer adverse-event records for SMITH & NEPHEW, INC. 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 · 1995–2026 · heavy-book · quiet Death-code · balanced

Volume signature

SMITH & NEPHEW, INC. sits in the heavy MAUDE book

SMITH & NEPHEW, INC. accounts for 81,431 FDA MAUDE reports (#36 of 443, heavy-book tercile). Death-coded event_type share is 0.05% (quiet); Injury share 38.1% (balanced).

What the volume reading shows for SMITH & NEPHEW, INC.

The standout signal for SMITH & NEPHEW, INC. is filing volume: 81,431 adverse-event reports in FDA MAUDE (#36 of 443, heavy-book). Death-coded event_type share sits at 0.05% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SMITH & NEPHEW, INC. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 50,244 (61.7% of event_type total). Peak single-year volume reaches 14,403 reports across 31 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

81,431
Total Reports
41
Event-type Death
31,052
Injury Reports
20
Device Types

Event Types

Malfunction 50,244 (61.7%)
Injury 31,052 (38.1%)
54 (0.1%)
Death 41 (0.1%)
Other 40 (0.0%)

Patient Outcomes

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

50,878 (51.7%)
R 13,616 (13.8%)
Hospitalization 12,985 (13.2%)
Required Intervention 10,903 (11.1%)
Other 6,371 (6.5%)
O 2,097 (2.1%)
H 1,277 (1.3%)
S 63 (0.1%)
Disability 62 (0.1%)
Death 49 (0.0%)
Life Threatening 29 (0.0%)
L 21 (0.0%)
Congenital Anomaly 12 (0.0%)
C 1 (0.0%)
D 1 (0.0%)

Yearly Trend

95
1995: 2
97
1997: 25
98
1998: 12
99
1999: 5
00
2000: 6
01
2001: 3
02
2002: 14
03
2003: 12
04
2004: 24
05
2005: 97
06
2006: 42
07
2007: 24
08
2008: 46
09
2009: 19
10
2010: 49
11
2011: 172
12
2012: 465
13
2013: 669
14
2014: 870
15
2015: 2,624
16
2016: 3,069
17
2017: 5,218
18
2018: 5,746
19
2019: 7,586
20
2020: 12,795
21
2021: 14,403
22
2022: 7,765
23
2023: 6,121
24
2024: 6,475
25
2025: 6,043
26
2026: 1,030