Prosthesis, Elbow, Semi-Constrained, Cemented
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 §888.3160 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#774 of 1000 · 704 reports · 1992–2026
- BOOK 704 reports
- RANK #774 of 1000
- DEATH 6 death-typed
- INJ 633 injury-typed
- MALF 62 malfunction
- SPAN 1992–2026
- PEAK 2024: 163
- PHOTO Resin
Nearest event-volume peer: Resin, Root Canal Filling (1 report gap)
Prosthesis, Elbow, Semi-Constrained, Cemented sits #774 of 1000 among tracked device types with 704 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
Prosthesis carries 89.9% INJURY-coded reports, 59.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.9% corpus 1.5% · below corpus mean (-0.7 pp)
- INJ 89.9% corpus 30.3% · above corpus mean (+59.6 pp)
- MALF 8.8% corpus 64.8% · below corpus mean (-56.0 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 38% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Oximeter
Oximeter, Tissue Saturation
706 reports
- Prosthesis (this)
Prosthesis, Elbow, Semi-Constrained, Cemented
704 reports
- Resin
Resin, Root Canal Filling
703 reports
- Coronary Cove…
Coronary Covered Stent
702 reports
- Lectins And P…
Lectins And Protectins
701 reports
- Accessories
Accessories, Photographic, For Endoscope (Exclude Light Sources)
698 reports
What this shows Prosthesis, Elbow, Semi-Constrained, Cemented carries 704 MAUDE reports, ranked #774 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 fell to 38 in 2025, down from an average of 96 in the two years before.
Related Entities for Prosthesis, Elbow, Semi-Constrained, Cemented
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Prosthesis: 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 (704 here).
Similar death-typed counts
Nearest other device types by death-typed report count (6 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Prosthesis 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 Prosthesis; 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.