BIOMET ORTHOPEDICS

FDA MAUDE device safety record · 2002–2025

What the Data Shows About BIOMET ORTHOPEDICS

BIOMET ORTHOPEDICS is associated with 34,434 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2025. Of the total, 191 are coded as death reports and 32,592 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 BIOMET ORTHOPEDICS 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 32,592 reports (94.7% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 20 years of MAUDE data, with the peak single-year volume reaching 8,875 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.

34,434
Total Reports
191
Death Reports
32,592
Injury Reports
20
Device Types

Event Types

Injury 32,592 (94.7%)
Malfunction 1,619 (4.7%)
Death 191 (0.6%)
26 (0.1%)
Other 6 (0.0%)

Patient Outcomes

Hospitalization 25,536 (42.7%)
R 24,893 (41.7%)
Required Intervention 4,588 (7.7%)
Other 2,276 (3.8%)
1,623 (2.7%)
Death 204 (0.3%)
S 181 (0.3%)
O 159 (0.3%)
Disability 112 (0.2%)
Life Threatening 85 (0.1%)
H 72 (0.1%)
Congenital Anomaly 10 (0.0%)
L 6 (0.0%)

Devices (20)

Compare Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) vs Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer →

Yearly Trend

02
2002: 2
03
2003: 5
04
2004: 10
05
2005: 9
06
2006: 3
07
2007: 7
08
2008: 5
09
2009: 210
10
2010: 586
11
2011: 978
12
2012: 2,415
13
2013: 6,023
14
2014: 8,875
15
2015: 4,777
16
2016: 4,612
17
2017: 5,901
18
2018: 11
23
2023: 1
24
2024: 2
25
2025: 2

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.