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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3027 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Bone Cement MID-BOOK · MAUDE
#185 of 1000 · 13,130 reports · 1992–2026
- BOOK 13,130 reports
- RANK #185 of 1000
- DEATH 469 death-typed
- INJ 9,684 injury-typed
- MALF 2,913 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 (90 report gap)
Bone Cement sits #185 of 1000 among tracked device types with 13,130 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 →
Injury-coded reports run above the device-type norm
Bone Cement carries 73.8% INJURY-coded reports, 43.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
- INJ 73.8% corpus 30.3% · above corpus mean (+43.5 pp)
- MALF 22.2% corpus 64.8% · below corpus mean (-42.6 pp)
Lead product-problem code Loss of or Failure to Bond is 48% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 37% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .
Bone Cement in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Bone Cement (this)
Bone Cement
13,130 reports
- Filler
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
13,040 reports
- Pulse-Generat…
Pulse-Generator, Pacemaker, External
13,014 reports
- Clamp
Clamp, Vascular
12,982 reports
- Electrode
Electrode, Ph, Stomach
12,853 reports
- Shoulder Pros…
Shoulder Prosthesis, Reverse Configuration
12,771 reports
What this shows Bone Cement carries 13,130 MAUDE reports, ranked #185 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (360) held close to the prior two-year average of 483.
Related Entities for Bone Cement
Top Manufacturers
Event Locations
Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. 1818910 →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Bone Cement: 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 (13,130 here).
Similar death-typed counts
Nearest other device types by death-typed report count (469 here), distinct from the volume row.
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.