2026 data FDA MAUDE openFDA

Prosthesis, Shoulder, Hemi-, Humeral, Metallic 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

#212 of 1000 · 9,877 reports · 1992–2026

  • BOOK 9,877 reports
  • RANK #212 of 1000
  • DEATH 34 death-typed
  • INJ 8,028 injury-typed
  • MALF 1,537 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 985
  • PHOTO Appliance

Nearest event-volume peer: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (105 report gap)

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented sits #212 of 1000 among tracked device types with 9,877 MAUDE reports spanning 1992–2026. 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 81.3% corpus 30.4% · above corpus mean (+50.8 pp)
  • MALF 15.6% corpus 64.5% · below corpus mean (-48.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 24% of manufacturer-tagged reports · Top event location is 50% 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, Hemi-, Humeral, Metallic Uncemented carries 9,877 MAUDE reports, ranked #212 of 1000.

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

Event Types

Injury 8,028 (81.3%)
Malfunction 1,537 (15.6%)
Other 271 (2.7%)
Death 34 (0.3%)
7 (0.1%)

Patient Outcomes

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

Required Intervention 6,454 (57.7%)
1,301 (11.6%)
Hospitalization 1,248 (11.2%)
R 1,120 (10.0%)
Other 807 (7.2%)
H 112 (1.0%)
O 59 (0.5%)
Death 34 (0.3%)
Disability 18 (0.2%)
S 16 (0.1%)
L 6 (0.1%)
Life Threatening 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,591
Device Dislodged or Dislocated 1,048
Insufficient Information 887
Fracture 424
Appropriate Term/Code Not Available 283
Break 273
Osseointegration Problem 240
Loss of Osseointegration 195
Naturally Worn 162
Difficult to Insert 145
Loosening of Implant Not Related to Bone-Ingrowth 136
Loss of or Failure to Bond 121
Unstable 110
Detachment of Device or Device Component 107
Patient Device Interaction Problem 105
Loose or Intermittent Connection 94
Migration or Expulsion of Device 82
Migration 64
Disassembly 51
Failure To Adhere Or Bond 39

Yearly Trend

92
1992: 2
96
1996: 3
97
1997: 8
98
1998: 7
99
1999: 10
00
2000: 6
01
2001: 7
02
2002: 6
03
2003: 13
04
2004: 24
05
2005: 41
06
2006: 38
07
2007: 128
08
2008: 259
09
2009: 156
10
2010: 225
11
2011: 241
12
2012: 254
13
2013: 288
14
2014: 434
15
2015: 574
16
2016: 784
17
2017: 985
18
2018: 649
19
2019: 830
20
2020: 658
21
2021: 573
22
2022: 509
23
2023: 586
24
2024: 693
25
2025: 766
26
2026: 120

Related Entities for Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Event Locations

4,976 (50.4%)
I 4,593 (46.5%)
HOSPITAL 276 (2.8%)
NO INFORMATION 18 (0.2%)
OTHER 4 (0.0%)
INVALID DATA 3 (0.0%)
UNKNOWN 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US 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.

Similar report volume

Nearest other device types by FDA MAUDE report count (9,877 here).

Similar death-typed counts

Nearest other device types by death-typed report count (34 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.