2026 data FDA MAUDE openFDA FDA Class I

Mixer, Cement, For Clinical Use

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §888.4210 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Mixer, Cement, For Clinical Use LIGHT-BOOK · MAUDE

#665 of 1000 · 998 reports · 1996–2026

  • BOOK 998 reports
  • RANK #665 of 1000
  • DEATH 4 death-typed
  • INJ 68 injury-typed
  • MALF 924 malfunction
  • SPAN 1996–2026
  • PEAK 2026: 228
  • PHOTO Filter

Nearest event-volume peer: Filter, Bacterial, Breathing-Circuit (6 report gap)

Mixer, Cement, For Clinical Use sits #665 of 1000 among tracked device types with 998 MAUDE reports spanning 1996–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Mixer, Cement, For Clinical Use carries 92.6% MALFUNCTION-coded reports, 27.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 6.8% corpus 30.3% · below corpus mean (-23.5 pp)
  • MALF 92.6% corpus 64.8% · above corpus mean (+27.8 pp)

Lead product-problem code Unsealed Device Packaging is 25% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 59% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Mixer, Cement, For Clinical Use in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Mixer, Cement, For Clinical Use carries 998 MAUDE reports, ranked #665 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 924 (92.6%)
Injury 68 (6.8%)
Death 4 (0.4%)
1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

899 (89.4%)
Other 47 (4.7%)
Required Intervention 38 (3.8%)
Hospitalization 8 (0.8%)
R 7 (0.7%)
Death 4 (0.4%)
H 1 (0.1%)
O 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Unsealed Device Packaging 229
Device Contaminated During Manufacture or Shipping 150
Detachment of Device or Device Component 81
Packaging Problem 79
Metal Shedding Debris 70
Break 66
Delivered as Unsterile Product 45
Leak/Splash 33
Disassembly 29
Material Disintegration 25
Biocompatibility 17
Device Operates Differently Than Expected 14
Tear, Rip or Hole in Device Packaging 12
Crack 9
Detachment Of Device Component 9
Device Contamination with Chemical or Other Material 9
Insufficient Device Problem Information 8
Fracture 7
Difficult to Remove 6
Flaked 6

Yearly Trend

96
1996: 11
97
1997: 8
98
1998: 9
99
1999: 1
00
2000: 1
01
2001: 4
02
2002: 8
03
2003: 4
05
2005: 1
06
2006: 3
07
2007: 5
08
2008: 12
09
2009: 6
10
2010: 11
11
2011: 24
12
2012: 26
13
2013: 67
14
2014: 44
15
2015: 49
16
2016: 16
17
2017: 21
18
2018: 22
19
2019: 33
20
2020: 167
21
2021: 58
22
2022: 46
23
2023: 65
24
2024: 28
25
2025: 20
26
2026: 228

Reports fell to 20 in 2025, down from an average of 47 in the two years before.

Related Entities for Mixer, Cement, For Clinical Use

Event Locations

605 (60.6%)
I 327 (32.8%)
HOSPITAL 54 (5.4%)
NO INFORMATION 6 (0.6%)
INVALID DATA 5 (0.5%)
OTHER 1 (0.1%)

Compare ZIMMER BIOMET, INC. vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mixer, Cement, For Clinical Use: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (998 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mixer, Cement, For Clinical Use are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Mixer, Cement, For Clinical Use; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.