Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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 §888.3310 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#468 of 1000 · 2,276 reports · 2015–2026
- BOOK 2,276 reports
- RANK #468 of 1000
- DEATH 2 death-typed
- INJ 1,072 injury-typed
- MALF 1,200 malfunction
- SPAN 2015–2026
- PEAK 2018: 278
- PHOTO Pulmonary Valve Prost…
Nearest event-volume peer: Pulmonary Valve Prosthesis Percutaneously Delivered (4 report gap)
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive sits #468 of 1000 among tracked device types with 2,276 MAUDE reports spanning 2015–2026. 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 47.1% INJURY-coded reports, 16.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 47.1% corpus 30.3% · above corpus mean (+16.8 pp)
- MALF 52.7% corpus 64.8% · below corpus mean (-12.1 pp)
Lead product-problem code Difficult to Insert is 25% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 85% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Knee, Hemi-, Femoral
2,314 reports
- Choledochosco…
Choledochoscope And Accessories, Flexible/Rigid
2,300 reports
- Pulmonary Val…
Pulmonary Valve Prosthesis Percutaneously Delivered
2,280 reports
- Prosthesis (this)
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
2,276 reports
- Implant
Implant, Anti-Gastroesophageal Reflux
2,236 reports
- Tray
Tray, Surgical, Instrument
2,231 reports
What this shows Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive carries 2,276 MAUDE reports, ranked #468 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 (237) held close to the prior two-year average of 255.
Related Entities for Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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 (2,276 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 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.