Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
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 III (highest risk, premarket approval required), regulated under 21 CFR §888.3380 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#441 of 1000 · 2,621 reports · 1994–2025
- BOOK 2,621 reports
- RANK #441 of 1000
- DEATH 4 death-typed
- INJ 2,516 injury-typed
- MALF 88 malfunction
- SPAN 1994–2025
- PEAK 2019: 354
- PHOTO Cerclage, Fixation
Nearest event-volume peer: Cerclage, Fixation (7 report gap)
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal sits #441 of 1000 among tracked device types with 2,621 MAUDE reports spanning 1994–2025. 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 96.0% INJURY-coded reports, 65.7pp 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 (-1.4 pp)
- INJ 96.0% corpus 30.3% · above corpus mean (+65.7 pp)
- MALF 3.4% corpus 64.8% · below corpus mean (-61.5 pp)
Lead product-problem code Insufficient Device Problem Information is 34% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 94% 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
- Handpiece
Handpiece, Contra- And Right-Angle Attachment, Dental
2,629 reports
- Device
Device, Anti-Snoring
2,628 reports
- Prosthesis (this)
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
2,621 reports
- Cerclage
Cerclage, Fixation
2,614 reports
- Catheter
Catheter, Conduction, Anesthetic
2,605 reports
- Catheter
Catheter, Urethral
2,601 reports
What this shows Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal carries 2,621 MAUDE reports, ranked #441 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 fell to 6 in 2024, down from an average of 40 in the two years before.
Related Entities for Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
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 (2,621 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 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.