DEPUY INTERNATIONAL LTD. 8010379

FDA MAUDE device safety record · 2008–2020

What the Data Shows About DEPUY INTERNATIONAL LTD. 8010379

DEPUY INTERNATIONAL LTD. 8010379 is associated with 14,451 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2020. Of the total, 123 are coded as death reports and 13,931 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 DEPUY INTERNATIONAL LTD. 8010379 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 13,931 reports (96.4% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 3,836 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.

14,451
Total Reports
123
Death Reports
13,931
Injury Reports
20
Device Types

Event Types

Injury 13,931 (96.4%)
Malfunction 392 (2.7%)
Death 123 (0.9%)
5 (0.0%)

Patient Outcomes

Required Intervention 12,833 (86.9%)
Other 845 (5.7%)
480 (3.3%)
R 297 (2.0%)
Death 157 (1.1%)
Hospitalization 132 (0.9%)
O 13 (0.1%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

08
2008: 2
09
2009: 3
10
2010: 66
11
2011: 775
12
2012: 1,179
13
2013: 1,094
14
2014: 3,836
15
2015: 1,986
16
2016: 1,886
17
2017: 1,595
18
2018: 1,036
19
2019: 990
20
2020: 3

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.