2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#757 of 1000 · 712 reports · 2014–2026

  • BOOK 712 reports
  • RANK #757 of 1000
  • DEATH 1 death-typed
  • INJ 637 injury-typed
  • MALF 73 malfunction
  • SPAN 2014–2026
  • PEAK 2017: 176
  • PHOTO Device

Nearest event-volume peer: Device, Intravascular Catheter Securement (2 report gap)

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented sits #757 of 1000 among tracked device types with 712 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 89.5% corpus 30.4% · above corpus mean (+59.0 pp)
  • MALF 10.3% corpus 64.5% · below corpus mean (-54.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer BIOMET ORTHOPEDICS accounts for 39% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Prosthesis in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented carries 712 MAUDE reports, ranked #757 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 637 (89.5%)
Malfunction 73 (10.3%)
1 (0.1%)
Death 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

R 286 (28.1%)
Hospitalization 271 (26.6%)
Required Intervention 230 (22.6%)
Other 140 (13.8%)
68 (6.7%)
O 15 (1.5%)
S 3 (0.3%)
H 2 (0.2%)
Death 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 231
Insufficient Information 103
Device Dislodged or Dislocated 79
Fracture 58
Unstable 55
Difficult to Insert 40
Migration or Expulsion of Device 20
Detachment Of Device Component 10
Appropriate Term/Code Not Available 9
Detachment of Device or Device Component 9
Difficult To Position 9
Mechanical Problem 9
Device-Device Incompatibility 8
Naturally Worn 8
Device Operates Differently Than Expected 7
Fitting Problem 6
Device Damaged by Another Device 5
Loose or Intermittent Connection 5
Loosening of Implant Not Related to Bone-Ingrowth 5
Malposition of Device 5

Yearly Trend

14
2014: 30
15
2015: 55
16
2016: 63
17
2017: 176
18
2018: 94
19
2019: 17
20
2020: 7
21
2021: 7
22
2022: 9
23
2023: 64
24
2024: 85
25
2025: 88
26
2026: 17

Related Entities for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

Event Locations

I 376 (52.8%)
335 (47.1%)
HOSPITAL 1 (0.1%)

Compare BIOMET ORTHOPEDICS vs ZIMMER BIOMET, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

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.