2026 data FDA MAUDE openFDA

Prosthesis, Elbow, Constrained, 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, Elbow, Constrained, Cemented LIGHT-BOOK · MAUDE

#395 of 1000 · 2,976 reports · 1992–2026

  • BOOK 2,976 reports
  • RANK #395 of 1000
  • DEATH 13 death-typed
  • INJ 2,762 injury-typed
  • MALF 195 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 401
  • PHOTO Latex Patient Examina…

Nearest event-volume peer: Latex Patient Examination Glove (9 report gap)

Prosthesis, Elbow, Constrained, Cemented sits #395 of 1000 among tracked device types with 2,976 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 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 92.8% corpus 30.4% · above corpus mean (+62.4 pp)
  • MALF 6.6% corpus 64.5% · below corpus mean (-58.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 31% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Prosthesis, Elbow, Constrained, Cemented in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Elbow, Constrained, Cemented carries 2,976 MAUDE reports, ranked #395 of 1000.

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

Event Types

Injury 2,762 (92.8%)
Malfunction 195 (6.6%)
Death 13 (0.4%)
Other 4 (0.1%)
2 (0.1%)

Patient Outcomes

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

Required Intervention 1,305 (31.2%)
R 1,006 (24.1%)
Hospitalization 932 (22.3%)
Other 558 (13.3%)
161 (3.9%)
H 128 (3.1%)
O 63 (1.5%)
Death 15 (0.4%)
S 5 (0.1%)
Disability 5 (0.1%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 586
Insufficient Information 382
Appropriate Term/Code Not Available 189
Loosening of Implant Not Related to Bone-Ingrowth 184
Fracture 175
Loose or Intermittent Connection 134
Migration or Expulsion of Device 121
Naturally Worn 111
Device Dislodged or Dislocated 64
Unstable 55
Break 36
Detachment of Device or Device Component 36
Migration 33
Failure To Adhere Or Bond 27
Malposition of Device 21
Packaging Problem 20
Device Markings/Labelling Problem 19
Difficult to Insert 19
Device Slipped 18
Loss of or Failure to Bond 18

Yearly Trend

92
1992: 1
94
1994: 2
96
1996: 3
97
1997: 3
98
1998: 4
99
1999: 6
00
2000: 5
01
2001: 11
02
2002: 12
03
2003: 21
04
2004: 14
05
2005: 33
06
2006: 41
07
2007: 33
08
2008: 47
09
2009: 45
10
2010: 86
11
2011: 62
12
2012: 79
13
2013: 74
14
2014: 79
15
2015: 239
16
2016: 176
17
2017: 401
18
2018: 244
19
2019: 190
20
2020: 179
21
2021: 157
22
2022: 129
23
2023: 188
24
2024: 175
25
2025: 216
26
2026: 21

Related Entities for Prosthesis, Elbow, Constrained, Cemented

Event Locations

I 1,452 (48.8%)
1,305 (43.9%)
HOSPITAL 199 (6.7%)
NO INFORMATION 7 (0.2%)
OTHER 3 (0.1%)
UNKNOWN 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
HOME 2 (0.1%)
INVALID DATA 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ZIMMER BIOMET, INC. vs ENCORE MEDICAL L.P. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Elbow, Constrained, Cemented, 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 (2,976 here).

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Elbow, Constrained, Cemented 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, Elbow, Constrained, Cemented; 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.