WARSAW ORTHOPEDICS

Manufacturer adverse-event records for WARSAW ORTHOPEDICS 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 · 2010–2025 · thin-book · typical Death-code · balanced

Volume signature

WARSAW ORTHOPEDICS is a thinner MAUDE footprint

WARSAW ORTHOPEDICS accounts for 3,709 FDA MAUDE reports (#428 of 443, thin-book tercile). Death-coded event_type share is 0.22% (typical); Injury share 48.0% (balanced).

What the volume reading shows for WARSAW ORTHOPEDICS

The standout signal for WARSAW ORTHOPEDICS is filing volume: 3,709 adverse-event reports in FDA MAUDE (#428 of 443, thin-book). Death-coded event_type share sits at 0.22% (typical).

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 20 device types, led in this extract by Malfunction at 1,902 (51.3% of event_type total). Peak single-year volume reaches 395 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,709
Total Reports
8
Event-type Death
1,782
Injury Reports
20
Device Types

Event Types

Malfunction 1,902 (51.3%)
Injury 1,782 (48.0%)
17 (0.5%)
Death 8 (0.2%)

Patient Outcomes

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

1,788 (45.5%)
Required Intervention 1,325 (33.7%)
Other 550 (14.0%)
R 193 (4.9%)
Hospitalization 20 (0.5%)
O 13 (0.3%)
Disability 11 (0.3%)
S 9 (0.2%)
Death 8 (0.2%)
H 5 (0.1%)
Life Threatening 4 (0.1%)

Yearly Trend

10
2010: 21
11
2011: 62
12
2012: 209
13
2013: 269
14
2014: 302
15
2015: 319
16
2016: 395
17
2017: 389
18
2018: 346
19
2019: 297
20
2020: 306
21
2021: 227
22
2022: 161
23
2023: 142
24
2024: 139
25
2025: 125