STRYKER ORTHOPAEDICS-MAHWAH

FDA MAUDE device safety record · 2009–2026

What the Data Shows About STRYKER ORTHOPAEDICS-MAHWAH

STRYKER ORTHOPAEDICS-MAHWAH is associated with 41,777 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2026. Of the total, 88 are coded as death reports and 34,661 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 STRYKER ORTHOPAEDICS-MAHWAH 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 Injury at 34,661 reports (83.0% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 5,056 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.

41,777
Total Reports
88
Death Reports
34,661
Injury Reports
20
Device Types

Event Types

Injury 34,661 (83.0%)
Malfunction 7,027 (16.8%)
Death 88 (0.2%)
Other 1 (0.0%)

Patient Outcomes

R 20,052 (30.5%)
Hospitalization 19,789 (30.1%)
Required Intervention 10,960 (16.7%)
Other 10,655 (16.2%)
H 3,047 (4.6%)
O 909 (1.4%)
179 (0.3%)
Death 86 (0.1%)
S 21 (0.0%)
Congenital Anomaly 10 (0.0%)
Disability 5 (0.0%)
D 3 (0.0%)
Life Threatening 2 (0.0%)
C 1 (0.0%)

Devices (20)

Compare Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented vs Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer →

Yearly Trend

09
2009: 1
10
2010: 5
12
2012: 33
13
2013: 4,244
14
2014: 5,056
15
2015: 4,505
16
2016: 4,056
17
2017: 3,774
18
2018: 4,164
19
2019: 4,127
20
2020: 2,724
21
2021: 2,081
22
2022: 1,944
23
2023: 1,600
24
2024: 1,785
25
2025: 1,534
26
2026: 144

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.