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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3027 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Bone Cement, Antibiotic LIGHT-BOOK · MAUDE
#365 of 1000 · 3,697 reports · 1992–2026
- BOOK 3,697 reports
- RANK #365 of 1000
- DEATH 48 death-typed
- INJ 1,888 injury-typed
- MALF 1,760 malfunction
- SPAN 1992–2026
- PEAK 2021: 649
- PHOTO Artificial Heart
Nearest event-volume peer: Artificial Heart (5 report gap)
Bone Cement, Antibiotic sits #365 of 1000 among tracked device types with 3,697 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, Antibiotic carries 51.1% INJURY-coded reports, 20.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
- INJ 51.1% corpus 30.3% · above corpus mean (+20.8 pp)
- MALF 47.6% corpus 64.8% · below corpus mean (-17.2 pp)
Lead product-problem code Loss of or Failure to Bond is 30% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 61% of manufacturer-tagged reports · Top event location I is 62% of location-tagged rows .
Bone Cement, Antibiotic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stapler, Skin
Stapler, Skin
3,772 reports
- Bone Cement (this)
Bone Cement, Antibiotic
3,697 reports
- Artificial He…
Artificial Heart
3,692 reports
- Syringe
Syringe, Balloon Inflation
3,683 reports
- Sensor
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
3,653 reports
- Tissue Adhesi…
Tissue Adhesive For The Topical Approximation Of Skin
3,631 reports
What this shows Bone Cement, Antibiotic carries 3,697 MAUDE reports, ranked #365 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 (175) held close to the prior two-year average of 238.
Related Entities for Bone Cement, Antibiotic
Top Manufacturers
Event Locations
Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 3015516266 →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Bone Cement, Antibiotic: 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 (3,697 here).
Similar death-typed counts
Nearest other device types by death-typed report count (48 here), distinct from the volume row.
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.