DEPUY IRELAND - 9616671

FDA MAUDE device safety record · 2009–2026

What the Data Shows About DEPUY IRELAND - 9616671

DEPUY IRELAND - 9616671 is associated with 45,087 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2026. Of the total, 23 are coded as death reports and 22,225 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 IRELAND - 9616671 should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 22,839 reports (50.7% of total). Patient-outcome categorizations are reported across 11 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 6,821 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.

45,087
Total Reports
23
Death Reports
22,225
Injury Reports
20
Device Types

Event Types

Malfunction 22,839 (50.7%)
Injury 22,225 (49.3%)
Death 23 (0.1%)

Patient Outcomes

22,617 (50.4%)
Required Intervention 21,981 (49.0%)
Other 104 (0.2%)
R 100 (0.2%)
Hospitalization 52 (0.1%)
Death 18 (0.0%)
D 10 (0.0%)
Life Threatening 4 (0.0%)
H 2 (0.0%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

09
2009: 1
10
2010: 1
11
2011: 4
12
2012: 16
13
2013: 27
14
2014: 16
15
2015: 61
16
2016: 67
17
2017: 477
18
2018: 2,359
19
2019: 4,725
20
2020: 6,035
21
2021: 6,626
22
2022: 5,479
23
2023: 6,099
24
2024: 6,821
25
2025: 5,408
26
2026: 865

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.