Prosthesis, Shoulder, Semi-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 §888.3660 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis MID-BOOK · MAUDE
#132 of 1000 · 23,248 reports · 1996–2026
- BOOK 23,248 reports
- RANK #132 of 1000
- DEATH 33 death-typed
- INJ 19,394 injury-typed
- MALF 2,538 malfunction
- SPAN 1996–2026
- PEAK 2025: 2,315
- PHOTO Screwdriver
Nearest event-volume peer: Screwdriver (8 report gap)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented sits #132 of 1000 among tracked device types with 23,248 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 →
Malfunction reports sit below the device-type norm
Prosthesis carries 10.9% MALFUNCTION-coded reports, 53.9pp below 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 83.4% corpus 30.3% · above corpus mean (+53.1 pp)
- MALF 10.9% corpus 64.8% · below corpus mean (-53.9 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 21% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Instrument
Instrument, Biopsy
23,840 reports
- Counter
Counter, Differential Cell
23,439 reports
- Stent
Stent, Coronary
23,279 reports
- Screwdriver
Screwdriver
23,256 reports
- Prosthesis (this)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
23,248 reports
- Implant
Implant, Dermal, For Aesthetic Use
22,615 reports
What this shows Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented carries 23,248 MAUDE reports, ranked #132 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 (2,315) held close to the prior two-year average of 1,936.
Related Entities for Prosthesis, Shoulder, Semi-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 (23,248 here).
Similar death-typed counts
Nearest other device types by death-typed report count (33 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.