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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3510 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#225 of 1000 · 9,364 reports · 1994–2026
- BOOK 9,364 reports
- RANK #225 of 1000
- DEATH 54 death-typed
- INJ 8,298 injury-typed
- MALF 984 malfunction
- SPAN 1994–2026
- PEAK 2025: 926
- PHOTO Catheter
Nearest event-volume peer: Catheter, Retention Type, Balloon (33 report gap)
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer sits #225 of 1000 among tracked device types with 9,364 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 →
Injury-coded reports run above the device-type norm
Prosthesis carries 88.6% INJURY-coded reports, 58.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 88.6% corpus 30.3% · above corpus mean (+58.3 pp)
- MALF 10.5% corpus 64.8% · below corpus mean (-54.3 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 36% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Keratome
Keratome, Ac-Powered
9,578 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
9,364 reports
- Catheter
Catheter, Retention Type, Balloon
9,331 reports
- Intervertebra…
Intervertebral Fusion Device With Bone Graft, Lumbar
9,183 reports
- Controller
Controller, Temperature, Cardiopulmonary Bypass
9,165 reports
- Negative Pres…
Negative Pressure Wound Therapy Powered Suction Pump
9,164 reports
What this shows Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer carries 9,364 MAUDE reports, ranked #225 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 (926) held close to the prior two-year average of 801.
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 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 (9,364 here).
Similar death-typed counts
Nearest other device types by death-typed report count (54 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.