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2026 data FDA MAUDE openFDA

Bone Cement, Antibiotic

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.

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FDA MAUDE casebook

openFDA event book Bone Cement, Antibiotic LIGHT-BOOK · MAUDE

#364 of 1000 · 3,616 reports · 1992–2026

  • BOOK 3,616 reports
  • RANK #364 of 1000
  • DEATH 47 death-typed
  • INJ 1,854 injury-typed
  • MALF 1,714 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 649
  • PHOTO Stapler, Skin

Nearest event-volume peer: Stapler, Skin (23 report gap)

Bone Cement, Antibiotic sits #364 of 1000 among tracked device types with 3,616 MAUDE reports spanning 1992–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 51.3% corpus 30.4% · above corpus mean (+20.8 pp)
  • MALF 47.4% corpus 64.5% · below corpus mean (-17.1 pp)

Lead product-problem code Loss of or Failure to Bond is 28% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 62% of manufacturer-tagged reports · Top event location I is 63% of location-tagged rows .

Bone Cement, Antibiotic in the event-volume neighbourhood

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

reports

What this shows Bone Cement, Antibiotic carries 3,616 MAUDE reports, ranked #364 of 1000.

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

Event Types

Injury 1,854 (51.3%)
Malfunction 1,714 (47.4%)
Death 47 (1.3%)
Other 1 (0.0%)

Patient Outcomes

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

1,695 (44.4%)
Required Intervention 1,557 (40.8%)
Hospitalization 154 (4.0%)
Other 148 (3.9%)
R 144 (3.8%)
H 44 (1.2%)
Death 44 (1.2%)
O 14 (0.4%)
Life Threatening 6 (0.2%)
S 3 (0.1%)
D 2 (0.1%)
Disability 2 (0.1%)
L 1 (0.0%)

Top Product Problems

Loss of or Failure to Bond 956
Unsealed Device Packaging 711
Adverse Event Without Identified Device or Use Problem 498
Infusion or Flow Problem 340
Chemical Problem 194
Improper Chemical Reaction 150
Loosening of Implant Not Related to Bone-Ingrowth 100
Insufficient Information 86
Tear, Rip or Hole in Device Packaging 59
Device Damaged Prior to Use 54
No Flow 53
Device Contaminated During Manufacture or Shipping 49
Patient Device Interaction Problem 44
Appropriate Term/Code Not Available 41
Migration 32
Difficult to Open or Remove Packaging Material 23
Loss of Osseointegration 20
Shipping Damage or Problem 19
Device Dislodged or Dislocated 18
Device Packaging Compromised 17

Yearly Trend

92
1992: 1
00
2000: 1
05
2005: 1
06
2006: 4
07
2007: 1
08
2008: 3
09
2009: 9
10
2010: 18
11
2011: 31
12
2012: 34
13
2013: 32
14
2014: 41
15
2015: 20
16
2016: 327
17
2017: 288
18
2018: 332
19
2019: 497
20
2020: 375
21
2021: 649
22
2022: 275
23
2023: 262
24
2024: 212
25
2025: 172
26
2026: 31

Related Entities for Bone Cement, Antibiotic

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 593
DEPUY IRELAND - 3015516266 159
DEPUY IRELAND - 9616671 98
STRYKER ORTHOPAEDICS-MAHWAH 67
DEPUY ORTHOPAEDICS, INC. 1818910 33

Event Locations

I 2,290 (63.3%)
1,303 (36.0%)
HOSPITAL 13 (0.4%)
NO INFORMATION 9 (0.2%)
UNKNOWN 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 3015516266 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Bone Cement, Antibiotic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,616 here).

Stapler, Skin 3,639 Transducer, Ultrasonic, Diagnostic 3,642 Syringe, Balloon Inflation 3,659 Artificial Heart 3,662

Similar death-typed counts

Nearest other device types by death-typed report count (47 here), distinct from the volume row.

Control, Pump Speed, Cardiopulmonary Bypass 47 Prosthesis 47 Warmer, Thermal, Infusion Fluid 47 Pulmonic Valved Conduit 48

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Bone Cement, Antibiotic 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 Bone Cement, Antibiotic; 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.