Prosthesis, Shoulder, Non-Constrained, Metal/Polymer 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 §888.3650 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#300 of 1000 · 5,649 reports · 1996–2026
- BOOK 5,649 reports
- RANK #300 of 1000
- DEATH 12 death-typed
- INJ 4,835 injury-typed
- MALF 710 malfunction
- SPAN 1996–2026
- PEAK 2025: 764
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (27 report gap)
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented sits #300 of 1000 among tracked device types with 5,649 MAUDE reports spanning 1996–2026. 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 85.6% INJURY-coded reports, 55.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 85.6% corpus 30.3% · above corpus mean (+55.3 pp)
- MALF 12.6% corpus 64.8% · below corpus mean (-52.3 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer EXACTECH, INC. accounts for 67% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter
Catheter, Irrigation
5,798 reports
- Warmer
Warmer, Infant Radiant
5,708 reports
- Prosthesis
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
5,676 reports
- Prosthesis (this)
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
5,649 reports
- Suture
Suture, Absorbable, Synthetic
5,585 reports
- Pump
Pump, Breast, Powered
5,556 reports
What this shows Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented carries 5,649 MAUDE reports, ranked #300 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 rose to 764 in 2025, up from an average of 482 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Prosthesis, Shoulder, Non-Constrained, Metal/Polymer 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 (5,649 here).
Similar death-typed counts
Nearest other device types by death-typed report count (12 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.