2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#130 of 1000 · 22,129 reports · 1996–2026

  • BOOK 22,129 reports
  • RANK #130 of 1000
  • DEATH 33 death-typed
  • INJ 18,358 injury-typed
  • MALF 2,455 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 2,318
  • PHOTO Screwdriver

Nearest event-volume peer: Screwdriver (352 report gap)

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented sits #130 of 1000 among tracked device types with 22,129 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 →

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 83.0% corpus 30.4% · above corpus mean (+52.5 pp)
  • MALF 11.1% corpus 64.5% · below corpus mean (-53.4 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 22% of manufacturer-tagged reports · Top event location is 57% 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 Cemented carries 22,129 MAUDE reports, ranked #130 of 1000.

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

Event Types

Injury 18,358 (83.0%)
Malfunction 2,455 (11.1%)
Other 1,214 (5.5%)
69 (0.3%)
Death 33 (0.1%)

Patient Outcomes

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

Required Intervention 13,149 (50.0%)
Other 3,764 (14.3%)
R 3,291 (12.5%)
Hospitalization 3,070 (11.7%)
2,049 (7.8%)
H 547 (2.1%)
O 306 (1.2%)
S 50 (0.2%)
Death 38 (0.1%)
Disability 28 (0.1%)
L 8 (0.0%)
Life Threatening 7 (0.0%)
Congenital Anomaly 4 (0.0%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 6,269
Device Dislodged or Dislocated 2,340
Insufficient Information 1,417
Fracture 1,404
Appropriate Term/Code Not Available 952
Unstable 911
Loosening of Implant Not Related to Bone-Ingrowth 770
Break 618
Detachment of Device or Device Component 428
Naturally Worn 420
Loose or Intermittent Connection 370
Loss of Osseointegration 331
Migration 284
Osseointegration Problem 270
Migration or Expulsion of Device 200
Difficult to Insert 197
Loss of or Failure to Bond 139
Patient Device Interaction Problem 129
Malposition of Device 119
Mechanical Problem 97

Yearly Trend

96
1996: 1
97
1997: 5
98
1998: 5
99
1999: 14
00
2000: 9
01
2001: 9
02
2002: 30
03
2003: 20
04
2004: 34
05
2005: 36
06
2006: 62
07
2007: 158
08
2008: 238
09
2009: 294
10
2010: 393
11
2011: 486
12
2012: 542
13
2013: 818
14
2014: 1,066
15
2015: 1,170
16
2016: 970
17
2017: 1,681
18
2018: 1,529
19
2019: 1,728
20
2020: 1,567
21
2021: 1,358
22
2022: 1,268
23
2023: 1,749
24
2024: 2,122
25
2025: 2,318
26
2026: 449

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

Event Locations

12,690 (57.3%)
I 9,132 (41.3%)
HOSPITAL 259 (1.2%)
NO INFORMATION 45 (0.2%)
HOME 1 (0.0%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare ZIMMER BIOMET, INC. vs TORNIER S.A.S. →

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 (22,129 here).

Similar death-typed counts

Nearest other device types by death-typed report count (33 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.