SMITH & NEPHEW MEDICAL LTD.

FDA MAUDE device safety record · 2007–2026

What the Data Shows About SMITH & NEPHEW MEDICAL LTD.

SMITH & NEPHEW MEDICAL LTD. is associated with 9,215 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2007 through 2026. Of the total, 11 are coded as death reports and 2,705 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for SMITH & NEPHEW MEDICAL LTD. should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 6,495 reports (70.5% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 14 years of MAUDE data, with the peak single-year volume reaching 4,409 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

9,215
Total Reports
11
Death Reports
2,705
Injury Reports
20
Device Types

Event Types

Malfunction 6,495 (70.5%)
Injury 2,705 (29.4%)
Death 11 (0.1%)
4 (0.0%)

Patient Outcomes

6,671 (67.8%)
Required Intervention 1,033 (10.5%)
Other 945 (9.6%)
R 575 (5.8%)
Hospitalization 522 (5.3%)
O 48 (0.5%)
S 14 (0.1%)
Death 14 (0.1%)
H 9 (0.1%)
Disability 4 (0.0%)
Life Threatening 2 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

07
2007: 6
08
2008: 4
15
2015: 283
16
2016: 181
17
2017: 318
18
2018: 429
19
2019: 981
20
2020: 4,409
21
2021: 2,067
22
2022: 211
23
2023: 94
24
2024: 108
25
2025: 114
26
2026: 10

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.