Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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 §888.3690 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis MID-BOOK · MAUDE
#216 of 1000 · 10,195 reports · 1992–2026
- BOOK 10,195 reports
- RANK #216 of 1000
- DEATH 34 death-typed
- INJ 8,314 injury-typed
- MALF 1,569 malfunction
- SPAN 1992–2026
- PEAK 2017: 985
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (10 report gap)
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented sits #216 of 1000 among tracked device types with 10,195 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 81.5% INJURY-coded reports, 51.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 81.5% corpus 30.3% · above corpus mean (+51.3 pp)
- MALF 15.4% corpus 64.8% · below corpus mean (-49.4 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 26% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Test, Automated Blood Grouping And Antibody
10,401 reports
- Plate, Bone
Plate, Bone
10,393 reports
- Catheter
Catheter, Coude
10,370 reports
- Prosthesis (this)
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
10,195 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
10,185 reports
- Saw
Saw, Powered, And Accessories
9,928 reports
What this shows Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented carries 10,195 MAUDE reports, ranked #216 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 (768) held close to the prior two-year average of 640.
Related Entities for Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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 (10,195 here).
Similar death-typed counts
Nearest other device types by death-typed report count (34 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.