ZIMMER MANUFACTURING B.V.

FDA MAUDE device safety record · 2006–2026

What the Data Shows About ZIMMER MANUFACTURING B.V.

ZIMMER MANUFACTURING B.V. is associated with 5,545 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2006 through 2026. Of the total, 24 are coded as death reports and 4,997 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 MANUFACTURING B.V. 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 4,997 reports (90.1% 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 21 years of MAUDE data, with the peak single-year volume reaching 881 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.

5,545
Total Reports
24
Death Reports
4,997
Injury Reports
20
Device Types

Event Types

Injury 4,997 (90.1%)
Malfunction 522 (9.4%)
Death 24 (0.4%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

Hospitalization 3,041 (32.9%)
R 3,010 (32.6%)
Other 994 (10.8%)
Required Intervention 927 (10.0%)
H 560 (6.1%)
516 (5.6%)
O 108 (1.2%)
Death 36 (0.4%)
Disability 17 (0.2%)
S 13 (0.1%)
Life Threatening 9 (0.1%)
L 6 (0.1%)
Congenital Anomaly 2 (0.0%)

Devices (20)

Compare Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer vs Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented →

Yearly Trend

06
2006: 15
07
2007: 54
08
2008: 49
09
2009: 35
10
2010: 8
11
2011: 4
12
2012: 21
13
2013: 10
14
2014: 50
15
2015: 61
16
2016: 427
17
2017: 731
18
2018: 841
19
2019: 881
20
2020: 526
21
2021: 445
22
2022: 252
23
2023: 313
24
2024: 410
25
2025: 381
26
2026: 31

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.