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2026 data FDA MAUDE openFDA FDA Class I

Joint, Knee, External Limb Component

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §890.3420 (Physical Medicine panel).

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FDA MAUDE casebook

openFDA event book Joint, Knee, External Limb Component LIGHT-BOOK · MAUDE

#897 of 1000 · 494 reports · 1992–2026

  • BOOK 494 reports
  • RANK #897 of 1000
  • DEATH 3 death-typed
  • INJ 252 injury-typed
  • MALF 227 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 87
  • PHOTO Angiography/Angioplas…

Nearest event-volume peer: Angiography/Angioplasty Kit (0 report gap)

Joint, Knee, External Limb Component sits #897 of 1000 among tracked device types with 494 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 → · Similar-volume device →

Injury-coded reports run above the device-type norm

Joint, Knee, External Limb Component carries 51.0% INJURY-coded reports, 20.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 51.0% corpus 30.3% · above corpus mean (+20.7 pp)
  • MALF 46.0% corpus 64.8% · below corpus mean (-18.9 pp)

Lead product-problem code Mechanical Problem is 34% of coded problems · Top event location I is 63% of location-tagged rows .

Joint, Knee, External Limb Component in the event-volume neighbourhood

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

reports

What this shows Joint, Knee, External Limb Component carries 494 MAUDE reports, ranked #897 of 1000.

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

Event Types

Injury 252 (51.0%)
Malfunction 227 (46.0%)
Other 9 (1.8%)
3 (0.6%)
Death 3 (0.6%)

Patient Outcomes

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

228 (37.1%)
Hospitalization 133 (21.6%)
R 98 (15.9%)
Required Intervention 75 (12.2%)
Other 47 (7.6%)
H 26 (4.2%)
O 3 (0.5%)
L 1 (0.2%)
S 1 (0.2%)
Death 1 (0.2%)
Disability 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Mechanical Problem 167
Unintended System Motion 68
Device Operates Differently Than Expected 66
Device Handling Problem 40
Insufficient Device Problem Information 29
Adverse Event Without Identified Device or Use Problem 24
Physical Resistance/Sticking 23
Unknown (for use when the device problem is not known) 15
Break 10
Device Slipped 8
Loose or Intermittent Connection 8
Fracture 6
Component Missing 4
Unintended Movement 4
Use of Device Problem 4
Collapse 3
Crack 2
Device remains implanted 2
Disconnection 2
Failure To Service 2

Yearly Trend

92
1992: 1
93
1993: 18
97
1997: 5
98
1998: 4
00
2000: 2
01
2001: 3
03
2003: 12
04
2004: 3
05
2005: 1
06
2006: 2
07
2007: 1
10
2010: 2
11
2011: 1
12
2012: 1
14
2014: 2
15
2015: 20
16
2016: 49
17
2017: 87
18
2018: 34
19
2019: 22
20
2020: 80
21
2021: 35
22
2022: 23
23
2023: 24
24
2024: 14
25
2025: 28
26
2026: 20

Reports rose to 28 in 2025, up from an average of 19 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Joint, Knee, External Limb Component

Event Locations

I 312 (63.2%)
142 (28.7%)
HOSPITAL 21 (4.3%)
HOME 7 (1.4%)
OTHER 5 (1.0%)
UNKNOWN 5 (1.0%)
INVALID DATA 1 (0.2%)
NO INFORMATION 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Joint, Knee, External Limb Component: 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 (494 here).

Angiography/Angioplasty Kit 494 Glue, Surgical, Arteries 495 Blood Pressure Cuff 492 Enzyme Linked Immunoabsorption Assay 492

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 Joint, Knee, External Limb Component 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 Joint, Knee, External Limb Component; 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.