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2026 data FDA MAUDE openFDA FDA Class I

Joint, Knee, External Brace

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 §890.3475 (Physical Medicine panel).

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FDA MAUDE casebook

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

#902 of 1000 · 489 reports · 1993–2026

  • BOOK 489 reports
  • RANK #902 of 1000
  • DEATH 0 death-typed
  • INJ 200 injury-typed
  • MALF 264 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 110
  • PHOTO Reservoir

Nearest event-volume peer: Reservoir, Blood, Cardiopulmonary Bypass (1 report gap)

Joint, Knee, External Brace sits #902 of 1000 among tracked device types with 489 MAUDE reports spanning 1993–2026. 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 →

Malfunction reports sit below the device-type norm

Joint, Knee, External Brace carries 54.0% MALFUNCTION-coded reports, 10.8pp below 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 40.9% corpus 30.3% · above corpus mean (+10.6 pp)
  • MALF 54.0% corpus 64.8% · below corpus mean (-10.8 pp)

Lead product-problem code Mechanical Problem is 28% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 100% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Joint, Knee, External Brace in the event-volume neighbourhood

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

reports

What this shows Joint, Knee, External Brace carries 489 MAUDE reports, ranked #902 of 1000.

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

Event Types

Malfunction 264 (54.0%)
Injury 200 (40.9%)
Other 18 (3.7%)
7 (1.4%)

Patient Outcomes

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

259 (50.6%)
Required Intervention 116 (22.7%)
Other 84 (16.4%)
Hospitalization 26 (5.1%)
R 17 (3.3%)
H 4 (0.8%)
Disability 2 (0.4%)
L 1 (0.2%)
O 1 (0.2%)
S 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Mechanical Problem 223
Unintended System Motion 221
No Apparent Adverse Event 127
Adverse Event Without Identified Device or Use Problem 99
Insufficient Device Problem Information 20
Unknown (for use when the device problem is not known) 19
Device Operates Differently Than Expected 12
Break 11
Patient Device Interaction Problem 11
Patient-Device Incompatibility 8
Other (for use when an appropriate device code cannot be identified) 7
Defective Device 5
Use of Device Problem 5
Collapse 4
Reaction 4
Component Missing 3
Component(s), broken 3
Detachment of Device or Device Component 3
Device Slipped 3
Locking mechanism failure 3

Yearly Trend

93
1993: 2
94
1994: 3
95
1995: 1
96
1996: 1
97
1997: 4
98
1998: 10
99
1999: 4
00
2000: 8
01
2001: 4
02
2002: 4
03
2003: 2
04
2004: 1
05
2005: 4
07
2007: 2
08
2008: 13
09
2009: 3
10
2010: 4
11
2011: 8
12
2012: 9
13
2013: 8
14
2014: 7
15
2015: 6
16
2016: 16
17
2017: 8
18
2018: 12
19
2019: 76
20
2020: 22
21
2021: 4
22
2022: 5
23
2023: 75
24
2024: 110
25
2025: 45
26
2026: 8

Reports fell to 45 in 2025, down from an average of 93 in the two years before.

Related Entities for Joint, Knee, External Brace

Top Manufacturers

BECTON DICKINSON 12

Event Locations

300 (61.3%)
I 132 (27.0%)
OTHER 19 (3.9%)
HOSPITAL 16 (3.3%)
HOME 9 (1.8%)
NO INFORMATION 6 (1.2%)
INVALID DATA 2 (0.4%)
UNKNOWN 2 (0.4%)
NURSING HOME 1 (0.2%)
OUTDOORS 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Joint, Knee, External Brace carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (489 here).

Reservoir, Blood, Cardiopulmonary Bypass 490 Blood Pressure Cuff 492 Enzyme Linked Immunoabsorption Assay 492 Percutaneous Catheter For Creation Of An Ar… 486

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Joint, Knee, External Brace 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 Brace; 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.