2026 data FDA MAUDE openFDA

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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

#278 of 1000 · 6,304 reports · 1994–2026

  • BOOK 6,304 reports
  • RANK #278 of 1000
  • DEATH 3 death-typed
  • INJ 6,065 injury-typed
  • MALF 224 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,666
  • PHOTO System

Nearest event-volume peer: System, Imaging, Pulsed Echo, Ultrasonic (31 report gap)

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer sits #278 of 1000 among tracked device types with 6,304 MAUDE reports spanning 1994–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 96.2% corpus 30.4% · above corpus mean (+65.8 pp)
  • MALF 3.6% corpus 64.5% · below corpus mean (-61.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 40% of coded problems · Lead manufacturer WRIGHT MEDICAL TECHNOLOGY INC accounts for 59% of manufacturer-tagged reports · Top event location is 77% 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, Ankle, Semi-Constrained, Cemented, Metal/Polymer carries 6,304 MAUDE reports, ranked #278 of 1000.

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

Event Types

Injury 6,065 (96.2%)
Malfunction 224 (3.6%)
6 (0.1%)
Other 6 (0.1%)
Death 3 (0.0%)

Patient Outcomes

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

Required Intervention 3,129 (44.6%)
Other 2,451 (35.0%)
Hospitalization 444 (6.3%)
R 427 (6.1%)
268 (3.8%)
H 209 (3.0%)
O 61 (0.9%)
S 11 (0.2%)
Disability 5 (0.1%)
Life Threatening 3 (0.0%)
Congenital Anomaly 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,588
Insufficient Information 1,120
Osseointegration Problem 1,080
Migration 541
Loss of Osseointegration 209
Fracture 125
Implant subsidence 123
Break 95
Loosening of Implant Not Related to Bone-Ingrowth 88
Malposition of Device 64
Naturally Worn 63
Appropriate Term/Code Not Available 60
Device Dislodged or Dislocated 56
Inadequacy of Device Shape and/or Size 47
Unstable 41
Migration or Expulsion of Device 39
Use of Device Problem 33
Loss of or Failure to Bond 28
Unintended Movement 25
Positioning Failure 24

Yearly Trend

94
1994: 1
95
1995: 1
98
1998: 2
99
1999: 2
01
2001: 1
02
2002: 21
03
2003: 13
04
2004: 22
05
2005: 31
06
2006: 34
07
2007: 50
08
2008: 66
09
2009: 66
10
2010: 120
11
2011: 139
12
2012: 100
13
2013: 106
14
2014: 65
15
2015: 73
16
2016: 111
17
2017: 96
18
2018: 185
19
2019: 277
20
2020: 281
21
2021: 237
22
2022: 453
23
2023: 796
24
2024: 1,095
25
2025: 1,666
26
2026: 194

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

Event Locations

4,825 (76.5%)
I 977 (15.5%)
HOSPITAL 456 (7.2%)
OTHER 19 (0.3%)
HOME 17 (0.3%)
NO INFORMATION 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
UNKNOWN 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare WRIGHT MEDICAL TECHNOLOGY INC vs WRIGHT MEDICAL TECHNOLOGY, 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.

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.