Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, 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 §888.3670 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#556 of 1000 · 1,564 reports · 2003–2026
- BOOK 1,564 reports
- RANK #556 of 1000
- DEATH 2 death-typed
- INJ 1,292 injury-typed
- MALF 266 malfunction
- SPAN 2003–2026
- PEAK 2025: 256
- PHOTO Device
Nearest event-volume peer: Device, Removal, Pacemaker Electrode, Percutaneous (3 report gap)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented sits #556 of 1000 among tracked device types with 1,564 MAUDE reports spanning 2003–2026. 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 82.6% INJURY-coded reports, 52.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 82.6% corpus 30.3% · above corpus mean (+52.3 pp)
- MALF 17.0% corpus 64.8% · below corpus mean (-47.8 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 36% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Tube
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
1,573 reports
- Wrench
Wrench
1,571 reports
- Mattress
Mattress, Flotation Therapy, Non-Powered
1,569 reports
- Prosthesis (this)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
1,564 reports
- Device
Device, Removal, Pacemaker Electrode, Percutaneous
1,561 reports
- Barrier
Barrier, Absorbable, Adhesion
1,558 reports
What this shows Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented carries 1,564 MAUDE reports, ranked #556 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 256 in 2025, up from an average of 154 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, 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 (1,564 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 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.