Prosthesis, Knee, Femorotibial, 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 MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#224 of 1000 · 8,981 reports · 1994–2026
- BOOK 8,981 reports
- RANK #224 of 1000
- DEATH 47 death-typed
- INJ 7,943 injury-typed
- MALF 963 malfunction
- SPAN 1994–2026
- PEAK 2025: 924
- PHOTO Controller
Nearest event-volume peer: Controller, Temperature, Cardiopulmonary Bypass (88 report gap)
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer sits #224 of 1000 among tracked device types with 8,981 MAUDE reports spanning 1994–2026. 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 88.4% corpus 30.4% · above corpus mean (+58.0 pp)
- MALF 10.7% corpus 64.5% · below corpus mean (-53.8 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 38% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 32% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Driver
Driver, Prosthesis
9,136 reports
- Negative Pres…
Negative Pressure Wound Therapy Powered Suction Pump
9,124 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
8,981 reports
- Controller
Controller, Temperature, Cardiopulmonary Bypass
8,893 reports
- Intervertebra…
Intervertebral Fusion Device With Bone Graft, Lumbar
8,876 reports
- Catheter
Catheter, Retention Type, Balloon
8,858 reports
What this shows Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer carries 8,981 MAUDE reports, ranked #224 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
Related Entities for Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Top Manufacturers
Event Locations
Compare STRYKER ORTHOPAEDICS-MAHWAH vs ZIMMER BIOMET, INC. →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Prosthesis, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (8,981 here).
Similar death-typed counts
Nearest other device types by death-typed report count (47 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.