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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3110 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#266 of 1000 · 6,959 reports · 1994–2026

  • BOOK 6,959 reports
  • RANK #266 of 1000
  • DEATH 3 death-typed
  • INJ 6,708 injury-typed
  • MALF 236 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,664
  • PHOTO Warmer

Nearest event-volume peer: Warmer, Thermal, Infusion Fluid (40 report gap)

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer sits #266 of 1000 among tracked device types with 6,959 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 →

Injury-coded reports run above the device-type norm

Prosthesis carries 96.4% INJURY-coded reports, 66.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 96.4% corpus 30.3% · above corpus mean (+66.1 pp)
  • MALF 3.4% corpus 64.8% · below corpus mean (-61.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer WRIGHT MEDICAL TECHNOLOGY INC accounts for 62% of manufacturer-tagged reports · Top event location is 79% 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 6,959 MAUDE reports, ranked #266 of 1000.

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

Event Types

Injury 6,708 (96.4%)
Malfunction 236 (3.4%)
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 3,296 (42.7%)
Other 2,867 (37.2%)
Hospitalization 479 (6.2%)
R 465 (6.0%)
278 (3.6%)
H 234 (3.0%)
O 71 (0.9%)
S 13 (0.2%)
Disability 7 (0.1%)
Life Threatening 3 (0.0%)
Congenital Anomaly 2 (0.0%)
C 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,926
Insufficient Device Problem Information 1,507
Osseointegration Problem 1,181
Migration 558
Loss of Osseointegration 339
Naturally Worn 193
Implant, removal of 189
Fracture 165
Implant subsidence 145
Break 120
Explanted 118
Loose 110
Loosening of Implant Not Related to Bone-Ingrowth 98
Appropriate Device Problem Term/Code Not Available 81
Malposition of Device 78
Migration or Expulsion of Device 78
Device Dislodged or Dislocated 68
Component(s), worn 63
Inadequacy of Device Shape and/or Size 54
Loss of or Failure to Bond 52

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: 1,664
26
2026: 851

Reports rose to 1,664 in 2025, up from an average of 946 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

WRIGHT MEDICAL TECHNOLOGY INC 3,906
WRIGHT MEDICAL TECHNOLOGY, INC. 851
DEPUY ORTHOPAEDICS, INC. 459
ZIMMER BIOMET, INC. 354
EXACTECH, INC. 329
DEPUY ORTHOPAEDICS INC US 150
STRYKER GMBH 150
ZIMMER, INC. 65
DEPUY WARSAW 64

Event Locations

5,481 (78.8%)
I 976 (14.0%)
HOSPITAL 456 (6.6%)
OTHER 19 (0.3%)
HOME 17 (0.2%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis: 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 (6,959 here).

Warmer, Thermal, Infusion Fluid 6,999 Continuous, Ventilator, Home Use 6,912 Prosthesis 6,886 Transcatheter Septal Occluder 6,884

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

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.