Prosthesis, Hip, Femoral Component, Cemented, Metal
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 §888.3360 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#275 of 1000 · 6,699 reports · 1992–2026
- BOOK 6,699 reports
- RANK #275 of 1000
- DEATH 11 death-typed
- INJ 3,176 injury-typed
- MALF 3,491 malfunction
- SPAN 1992–2026
- PEAK 2021: 1,206
- PHOTO Hearing Aid
Nearest event-volume peer: Hearing Aid, Bone Conduction, Implanted (21 report gap)
Prosthesis, Hip, Femoral Component, Cemented, Metal sits #275 of 1000 among tracked device types with 6,699 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 47.4% INJURY-coded reports, 17.1pp 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 47.4% corpus 30.3% · above corpus mean (+17.1 pp)
- MALF 52.1% corpus 64.8% · below corpus mean (-12.7 pp)
Lead product-problem code Break is 29% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 70% 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
- Toothbrush
Toothbrush, Powered
6,787 reports
- Prosthesis
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
6,780 reports
- Container
Container, I.V.
6,755 reports
- Prosthesis (this)
Prosthesis, Hip, Femoral Component, Cemented, Metal
6,699 reports
- Hearing Aid
Hearing Aid, Bone Conduction, Implanted
6,678 reports
- Ureteroscope…
Ureteroscope And Accessories, Flexible/Rigid
6,637 reports
What this shows Prosthesis, Hip, Femoral Component, Cemented, Metal carries 6,699 MAUDE reports, ranked #275 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 (265) held close to the prior two-year average of 295.
Related Entities for Prosthesis, Hip, Femoral Component, Cemented, Metal
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 (6,699 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11 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.