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2026 data FDA MAUDE openFDA

Bone Cement

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 MID-BOOK · MAUDE

#182 of 1000 · 13,039 reports · 1992–2026

  • BOOK 13,039 reports
  • RANK #182 of 1000
  • DEATH 465 death-typed
  • INJ 9,624 injury-typed
  • MALF 2,887 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 2,307
  • PHOTO Filler

Nearest event-volume peer: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction (26 report gap)

Bone Cement sits #182 of 1000 among tracked device types with 13,039 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 3.6% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 73.8% corpus 30.4% · above corpus mean (+43.4 pp)
  • MALF 22.1% corpus 64.5% · below corpus mean (-42.4 pp)

Lead product-problem code Loss of or Failure to Bond is 48% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 39% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .

Bone Cement in the event-volume neighbourhood

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

reports

What this shows Bone Cement carries 13,039 MAUDE reports, ranked #182 of 1000.

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

Event Types

Injury 9,624 (73.8%)
Malfunction 2,887 (22.1%)
Death 465 (3.6%)
Other 37 (0.3%)
26 (0.2%)

Patient Outcomes

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

Required Intervention 8,187 (58.4%)
1,918 (13.7%)
Other 1,739 (12.4%)
R 748 (5.3%)
Hospitalization 746 (5.3%)
Death 404 (2.9%)
H 95 (0.7%)
O 57 (0.4%)
S 51 (0.4%)
Life Threatening 27 (0.2%)
L 25 (0.2%)
Disability 12 (0.1%)
D 4 (0.0%)
Invalid Data 2 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Loss of or Failure to Bond 4,335
Adverse Event Without Identified Device or Use Problem 1,551
Loosening of Implant Not Related to Bone-Ingrowth 438
Insufficient Information 420
Loose or Intermittent Connection 273
Chemical Problem 257
Loss of Osseointegration 217
Migration or Expulsion of Device 196
Appropriate Term/Code Not Available 191
Unsealed Device Packaging 185
Device Damaged Prior to Use 126
Break 123
Device Difficult to Setup or Prepare 100
Failure To Adhere Or Bond 94
Tear, Rip or Hole in Device Packaging 87
Patient Device Interaction Problem 86
Device Operates Differently Than Expected 85
Migration 84
Failure to Eject 81
Packaging Problem 72

Yearly Trend

92
1992: 10
93
1993: 19
94
1994: 31
95
1995: 21
96
1996: 74
97
1997: 212
98
1998: 142
99
1999: 72
00
2000: 60
01
2001: 48
02
2002: 48
03
2003: 88
04
2004: 84
05
2005: 73
06
2006: 86
07
2007: 78
08
2008: 134
09
2009: 169
10
2010: 291
11
2011: 428
12
2012: 412
13
2013: 501
14
2014: 465
15
2015: 529
16
2016: 615
17
2017: 817
18
2018: 1,295
19
2019: 2,307
20
2020: 1,294
21
2021: 782
22
2022: 472
23
2023: 475
24
2024: 492
25
2025: 363
26
2026: 52

Related Entities for Bone Cement

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 1,638
DEPUY ORTHOPAEDICS, INC. 1818910 1,329
STRYKER ORTHOPAEDICS-MAHWAH 873
ZIMMER BIOMET, INC. 363

Event Locations

I 7,136 (54.7%)
5,068 (38.9%)
HOSPITAL 732 (5.6%)
NO INFORMATION 42 (0.3%)
INVALID DATA 27 (0.2%)
UNKNOWN 17 (0.1%)
HOME 8 (0.1%)
OTHER 5 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. 1818910 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Bone Cement, 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 (13,039 here).

Filler 13,013 Pulse Generator 13,091 Pulse-Generator, Pacemaker, External 12,771 Catheter, Steerable 12,715

Similar death-typed counts

Nearest other device types by death-typed report count (465 here), distinct from the volume row.

Electrosurgical 456 Oxygenator, Cardiopulmonary Bypass 445 Catheter, Intravascular, Diagnostic 444 Device 492

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

Disclaimer: MAUDE figures for Bone Cement 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; 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.