2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#568 of 1000 · 1,446 reports · 2003–2026

  • BOOK 1,446 reports
  • RANK #568 of 1000
  • DEATH 2 death-typed
  • INJ 1,185 injury-typed
  • MALF 255 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 258
  • PHOTO Electrode

Nearest event-volume peer: Electrode, Electrocardiograph (9 report gap)

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented sits #568 of 1000 among tracked device types with 1,446 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 →

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 82.0% corpus 30.4% · above corpus mean (+51.5 pp)
  • MALF 17.6% corpus 64.5% · below corpus mean (-46.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 36% of manufacturer-tagged reports · Top event location is 65% 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, Uncemented carries 1,446 MAUDE reports, ranked #568 of 1000.

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

Event Types

Injury 1,185 (82.0%)
Malfunction 255 (17.6%)
Other 4 (0.3%)
Death 2 (0.1%)

Patient Outcomes

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

Required Intervention 570 (29.2%)
Hospitalization 394 (20.2%)
R 376 (19.2%)
Other 248 (12.7%)
231 (11.8%)
H 104 (5.3%)
O 23 (1.2%)
S 6 (0.3%)
D 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 466
Insufficient Information 187
Break 120
Unstable 106
Device Dislodged or Dislocated 88
Loosening of Implant Not Related to Bone-Ingrowth 50
Device-Device Incompatibility 40
Detachment of Device or Device Component 32
Fracture 28
Migration or Expulsion of Device 28
Naturally Worn 25
Noise, Audible 18
Appropriate Term/Code Not Available 16
Material Deformation 16
Patient Device Interaction Problem 16
Packaging Problem 14
Difficult to Insert 13
Migration 12
Inadequacy of Device Shape and/or Size 10
Osseointegration Problem 10

Yearly Trend

03
2003: 2
05
2005: 2
06
2006: 3
07
2007: 2
08
2008: 7
09
2009: 16
10
2010: 24
11
2011: 32
12
2012: 30
13
2013: 40
14
2014: 28
15
2015: 49
16
2016: 85
17
2017: 193
18
2018: 99
19
2019: 47
20
2020: 24
21
2021: 36
22
2022: 114
23
2023: 143
24
2024: 164
25
2025: 258
26
2026: 48

Related Entities for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Event Locations

946 (65.4%)
I 475 (32.8%)
HOSPITAL 24 (1.7%)
NO INFORMATION 1 (0.1%)

Compare ZIMMER BIOMET, INC. vs DEPUY IRELAND - 3015516266 →

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.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,446 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

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.