Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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 §888.3660 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#757 of 1000 · 755 reports · 2014–2026
- BOOK 755 reports
- RANK #757 of 1000
- DEATH 1 death-typed
- INJ 679 injury-typed
- MALF 74 malfunction
- SPAN 2014–2026
- PEAK 2017: 176
- PHOTO Mesh
Nearest event-volume peer: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (1 report gap)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented sits #757 of 1000 among tracked device types with 755 MAUDE reports spanning 2014–2026. 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 89.9% INJURY-coded reports, 59.6pp 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 89.9% corpus 30.3% · above corpus mean (+59.6 pp)
- MALF 9.8% corpus 64.8% · below corpus mean (-55.0 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer BIOMET ORTHOPEDICS accounts for 37% 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
- Mesh
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
756 reports
- Punch
Punch, Surgical
756 reports
- Prosthesis (this)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
755 reports
- Catheter
Catheter, Balloon, Transcervical
753 reports
- Catheter
Catheter, Balloon Type
751 reports
- Extractor
Extractor, Vacuum, Fetal
751 reports
What this shows Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented carries 755 MAUDE reports, ranked #757 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 (88) held close to the prior two-year average of 75.
Related Entities for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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 (755 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 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.