2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Ankle, Uncemented, Non-Constrained

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

#537 of 1000 · 1,692 reports · 2009–2026

  • BOOK 1,692 reports
  • RANK #537 of 1000
  • DEATH 18 death-typed
  • INJ 1,580 injury-typed
  • MALF 93 malfunction
  • SPAN 2009–2026
  • PEAK 2020: 545
  • PHOTO Covid-19 Multi-Analyt…

Nearest event-volume peer: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices (1 report gap)

Prosthesis, Ankle, Uncemented, Non-Constrained sits #537 of 1000 among tracked device types with 1,692 MAUDE reports spanning 2009–2026. 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 93.4% INJURY-coded reports, 63.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 93.4% corpus 30.3% · above corpus mean (+63.1 pp)
  • MALF 5.5% corpus 64.8% · below corpus mean (-59.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 45% of coded problems · Lead manufacturer STRYKER GMBH accounts for 92% of manufacturer-tagged reports · Top event location I is 78% 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, Uncemented, Non-Constrained carries 1,692 MAUDE reports, ranked #537 of 1000.

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

Event Types

Injury 1,580 (93.4%)
Malfunction 93 (5.5%)
Death 18 (1.1%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 1,398 (80.9%)
Other 225 (13.0%)
22 (1.3%)
Hospitalization 20 (1.2%)
Death 19 (1.1%)
R 17 (1.0%)
S 12 (0.7%)
Disability 6 (0.3%)
H 5 (0.3%)
O 4 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 786
Insufficient Device Problem Information 191
Fracture 137
Break 107
Appropriate Device Problem Term/Code Not Available 93
Loss of Osseointegration 74
Unstable 58
Naturally Worn 56
Malposition of Device 41
Device Operates Differently Than Expected 29
Inadequacy of Device Shape and/or Size 29
Device Dislodged or Dislocated 27
Device Slipped 19
Patient-Device Incompatibility 17
Loose or Intermittent Connection 14
Migration 14
Unintended Movement 14
Improper or Incorrect Procedure or Method 12
Migration or Expulsion of Device 9
Material Deformation 8

Yearly Trend

09
2009: 2
10
2010: 19
11
2011: 15
12
2012: 19
13
2013: 30
14
2014: 92
15
2015: 341
16
2016: 86
17
2017: 82
18
2018: 93
19
2019: 129
20
2020: 545
21
2021: 89
22
2022: 50
23
2023: 12
24
2024: 22
25
2025: 14
26
2026: 52

Reports in 2025 (14) held close to the prior two-year average of 17.

Related Entities for Prosthesis, Ankle, Uncemented, Non-Constrained

Event Locations

I 1,318 (77.9%)
308 (18.2%)
HOSPITAL 59 (3.5%)
NO INFORMATION 7 (0.4%)

Compare STRYKER GMBH vs ENCORE MEDICAL L.P. →

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 (1,692 here).

Similar death-typed counts

Nearest other device types by death-typed report count (18 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.