Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
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 MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#315 of 1000 · 5,146 reports · 2007–2026
- BOOK 5,146 reports
- RANK #315 of 1000
- DEATH 58 death-typed
- INJ 4,885 injury-typed
- MALF 196 malfunction
- SPAN 2007–2026
- PEAK 2017: 676
- PHOTO Tissue Expander And A…
Nearest event-volume peer: Tissue Expander And Accessories (2 report gap)
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing sits #315 of 1000 among tracked device types with 5,146 MAUDE reports spanning 2007–2026. 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 94.9% INJURY-coded reports, 64.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
- INJ 94.9% corpus 30.3% · above corpus mean (+64.6 pp)
- MALF 3.8% corpus 64.8% · below corpus mean (-61.0 pp)
Lead product-problem code Insufficient Device Problem Information is 27% of coded problems · Lead manufacturer BIOMET UK LTD. accounts for 78% of manufacturer-tagged reports · Top event location I is 52% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Light
Light, Surgical, Ceiling Mounted
5,203 reports
- Prosthesis
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
5,172 reports
- Anesthesia Co…
Anesthesia Conduction Kit
5,152 reports
- Tissue Expand…
Tissue Expander And Accessories
5,148 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
5,146 reports
- Accessories
Accessories, Arthroscopic
5,126 reports
What this shows Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing carries 5,146 MAUDE reports, ranked #315 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 rose to 446 in 2025, up from an average of 269 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
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 (5,146 here).
Similar death-typed counts
Nearest other device types by death-typed report count (58 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.