2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3150 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis, Elbow, Constrained, Cemented LIGHT-BOOK · MAUDE

#406 of 1000 · 3,057 reports · 1992–2026

  • BOOK 3,057 reports
  • RANK #406 of 1000
  • DEATH 13 death-typed
  • INJ 2,840 injury-typed
  • MALF 198 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 401
  • PHOTO Agent

Nearest event-volume peer: Agent, Injectable, Embolic (5 report gap)

Prosthesis, Elbow, Constrained, Cemented sits #406 of 1000 among tracked device types with 3,057 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 →

Injury-coded reports run above the device-type norm

Prosthesis, Elbow, Constrained, Cemented carries 92.9% INJURY-coded reports, 62.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 92.9% corpus 30.3% · above corpus mean (+62.6 pp)
  • MALF 6.5% corpus 64.8% · below corpus mean (-58.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 19% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 31% of manufacturer-tagged reports · Top event location I is 47% 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 3,057 MAUDE reports, ranked #406 of 1000.

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

Event Types

Injury 2,840 (92.9%)
Malfunction 198 (6.5%)
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 1,355 (31.7%)
R 1,018 (23.8%)
Hospitalization 945 (22.1%)
Other 568 (13.3%)
163 (3.8%)
H 138 (3.2%)
O 66 (1.5%)
Death 15 (0.4%)
S 6 (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 643
Insufficient Device Problem Information 511
Fracture 280
Appropriate Device Problem Term/Code Not Available 232
Explanted 210
Loosening of Implant Not Related to Bone-Ingrowth 204
Loose or Intermittent Connection 185
Naturally Worn 145
Migration or Expulsion of Device 140
Device Dislodged or Dislocated 117
Break 102
Device Slipped 84
Failure To Adhere Or Bond 81
Loose 76
Implant, removal of 68
Unstable 66
Component(s), worn 65
Replace 55
Disassembly 47
Detachment of Device or Device Component 39

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: 187
24
2024: 175
25
2025: 216
26
2026: 103

Reports in 2025 (216) held close to the prior two-year average of 181.

Related Entities for Prosthesis, Elbow, Constrained, Cemented

Event Locations

I 1,452 (47.5%)
1,386 (45.3%)
HOSPITAL 199 (6.5%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Elbow, Constrained, Cemented: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,057 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.