Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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 §888.3560 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis HEAVY-BOOK · MAUDE
#26 of 1000 · 157,471 reports · 1992–2026
- BOOK 157,471 reports
- RANK #26 of 1000
- DEATH 262 death-typed
- INJ 132,428 injury-typed
- MALF 23,114 malfunction
- SPAN 1992–2026
- PEAK 2019: 14,987
- PHOTO Ventricular Bypass
Nearest event-volume peer: Ventricular (Assist) Bypass (40 report gap)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer sits #26 of 1000 among tracked device types with 157,471 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 84.1% INJURY-coded reports, 53.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 84.1% corpus 30.3% · above corpus mean (+53.8 pp)
- MALF 14.7% corpus 64.8% · below corpus mean (-50.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 25% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 22% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Integrated Co…
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
165,468 reports
- System
System, Peritoneal, Automatic Delivery
164,500 reports
- Prosthesis (this)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
157,471 reports
- Ventricular B…
Ventricular (Assist) Bypass
157,431 reports
- Implantable P…
Implantable Pulse Generator, Pacemaker (Non-Crt)
156,369 reports
- Wearable Auto…
Wearable Automated External Defibrillator
148,775 reports
What this shows Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer carries 157,471 MAUDE reports, ranked #26 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 (9,429) held close to the prior two-year average of 9,888.
Related Entities for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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 (157,471 here).
Similar death-typed counts
Nearest other device types by death-typed report count (262 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.