ZIMMER BIOMET, INC.

FDA MAUDE device safety record · 2012–2026

What the Data Shows About ZIMMER BIOMET, INC.

ZIMMER BIOMET, INC. is associated with 79,360 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2012 through 2026. Of the total, 311 are coded as death reports and 52,543 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 ZIMMER BIOMET, INC. 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 Injury at 52,543 reports (66.2% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 15 years of MAUDE data, with the peak single-year volume reaching 17,336 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.

79,360
Total Reports
311
Death Reports
52,543
Injury Reports
20
Device Types

Event Types

Injury 52,543 (66.2%)
Malfunction 26,506 (33.4%)
Death 311 (0.4%)

Patient Outcomes

Hospitalization 27,980 (24.3%)
R 27,212 (23.6%)
26,488 (23.0%)
Other 12,841 (11.1%)
Required Intervention 11,285 (9.8%)
H 7,250 (6.3%)
O 1,533 (1.3%)
Death 329 (0.3%)
S 118 (0.1%)
Disability 81 (0.1%)
Life Threatening 50 (0.0%)
L 37 (0.0%)
D 35 (0.0%)
Congenital Anomaly 8 (0.0%)
C 1 (0.0%)

Yearly Trend

12
2012: 5
13
2013: 11
14
2014: 43
15
2015: 82
16
2016: 40
17
2017: 6,249
18
2018: 17,336
19
2019: 10,539
20
2020: 8,112
21
2021: 6,703
22
2022: 6,208
23
2023: 6,607
24
2024: 7,141
25
2025: 9,174
26
2026: 1,110

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.