Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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 §888.3520 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#449 of 1000 · 2,520 reports · 1993–2026
- BOOK 2,520 reports
- RANK #449 of 1000
- DEATH 1 death-typed
- INJ 1,948 injury-typed
- MALF 548 malfunction
- SPAN 1993–2026
- PEAK 2020: 273
- PHOTO Gauze/Sponge
Nearest event-volume peer: Gauze/Sponge, Internal, X-Ray Detectable (1 report gap)
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer sits #449 of 1000 among tracked device types with 2,520 MAUDE reports spanning 1993–2026. 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 77.3% INJURY-coded reports, 47.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 77.3% corpus 30.3% · above corpus mean (+47.0 pp)
- MALF 21.7% corpus 64.8% · below corpus mean (-43.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 43% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Mattress
Mattress, Air Flotation, Alternating Pressure
2,524 reports
- Gauze/Sponge
Gauze/Sponge, Internal, X-Ray Detectable
2,521 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
2,520 reports
- Aid, Transfer
Aid, Transfer
2,515 reports
- Suture
Suture, Absorbable, Natural
2,489 reports
- Tube
Tube, Bronchial (W/Wo Connector)
2,475 reports
What this shows Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer carries 2,520 MAUDE reports, ranked #449 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 (178) held close to the prior two-year average of 202.
Related Entities for Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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 (2,520 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 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.