STRYKER ORTHOPAEDICS CORK

FDA MAUDE device safety record · 2004–2015

What the Data Shows About STRYKER ORTHOPAEDICS CORK

STRYKER ORTHOPAEDICS CORK is associated with 5,035 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2015. Of the total, 3 are coded as death reports and 3,964 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 CORK should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 3,964 reports (78.7% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 1,353 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.

5,035
Total Reports
3
Death Reports
3,964
Injury Reports
20
Device Types

Event Types

Injury 3,964 (78.7%)
Malfunction 1,024 (20.3%)
Other 43 (0.9%)
Death 3 (0.1%)
1 (0.0%)

Patient Outcomes

Other 2,696 (45.9%)
Required Intervention 2,199 (37.4%)
R 827 (14.1%)
121 (2.1%)
O 14 (0.2%)
Hospitalization 11 (0.2%)
Death 6 (0.1%)
Disability 2 (0.0%)
H 1 (0.0%)

Devices (20)

Compare Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate vs Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented →

Yearly Trend

04
2004: 47
05
2005: 121
06
2006: 128
07
2007: 166
08
2008: 414
09
2009: 631
10
2010: 842
11
2011: 833
12
2012: 1,353
13
2013: 158
14
2014: 332
15
2015: 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.