ZIMMER GMBH

FDA MAUDE device safety record · 2004–2026

What the Data Shows About ZIMMER GMBH

ZIMMER GMBH is associated with 14,925 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2026. Of the total, 37 are coded as death reports and 11,363 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 GMBH 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 11,363 reports (76.1% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 23 years of MAUDE data, with the peak single-year volume reaching 1,926 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.

14,925
Total Reports
37
Death Reports
11,363
Injury Reports
20
Device Types

Event Types

Injury 11,363 (76.1%)
Other 2,247 (15.1%)
Malfunction 990 (6.6%)
288 (1.9%)
Death 37 (0.2%)

Patient Outcomes

Hospitalization 8,443 (35.0%)
R 7,971 (33.0%)
Other 4,688 (19.4%)
907 (3.8%)
Required Intervention 768 (3.2%)
H 688 (2.9%)
O 584 (2.4%)
Death 32 (0.1%)
Life Threatening 23 (0.1%)
L 17 (0.1%)
D 5 (0.0%)
Congenital Anomaly 4 (0.0%)
Disability 3 (0.0%)
S 1 (0.0%)

Yearly Trend

04
2004: 3
05
2005: 1
06
2006: 13
07
2007: 66
08
2008: 352
09
2009: 568
10
2010: 780
11
2011: 541
12
2012: 800
13
2013: 1,073
14
2014: 1,926
15
2015: 1,430
16
2016: 1,481
17
2017: 1,817
18
2018: 1,227
19
2019: 765
20
2020: 199
21
2021: 5
22
2022: 9
23
2023: 140
24
2024: 632
25
2025: 985
26
2026: 112

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.