BIOMET UK LTD.

FDA MAUDE device safety record · 2005–2026

What the Data Shows About BIOMET UK LTD.

BIOMET UK LTD. is associated with 9,809 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2005 through 2026. Of the total, 49 are coded as death reports and 8,769 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 UK LTD. 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 8,769 reports (89.4% 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 22 years of MAUDE data, with the peak single-year volume reaching 1,275 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.

9,809
Total Reports
49
Death Reports
8,769
Injury Reports
20
Device Types

Event Types

Injury 8,769 (89.4%)
Malfunction 987 (10.1%)
Death 49 (0.5%)
3 (0.0%)
Other 1 (0.0%)

Patient Outcomes

Hospitalization 6,575 (38.4%)
R 6,362 (37.2%)
Required Intervention 1,229 (7.2%)
1,046 (6.1%)
Other 843 (4.9%)
H 819 (4.8%)
O 94 (0.5%)
Death 58 (0.3%)
S 36 (0.2%)
Life Threatening 21 (0.1%)
Disability 19 (0.1%)
Congenital Anomaly 11 (0.1%)
L 4 (0.0%)

Yearly Trend

05
2005: 5
06
2006: 1
07
2007: 12
08
2008: 26
09
2009: 56
10
2010: 122
11
2011: 211
12
2012: 375
13
2013: 340
14
2014: 396
15
2015: 604
16
2016: 941
17
2017: 1,234
18
2018: 1,275
19
2019: 937
20
2020: 550
21
2021: 530
22
2022: 485
23
2023: 430
24
2024: 494
25
2025: 685
26
2026: 100

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.