What are FDA adverse event reports for Prosthesis, Knee, Hemi-, Femoral?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Prosthesis, Knee, Hemi-, Femoral, there are 2,314 total reports including 1 death reports and 1,989 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Prosthesis, Knee, Hemi-, Femoral?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Prosthesis, Knee, Hemi-, Femoral

Name: Prosthesis, Knee, Hemi-, Femoral - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §888.3570 (Orthopedic panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Prosthesis, Knee, Hemi-, Femoral LIGHT-BOOK · MAUDE

#465 of 1000 · 2,314 reports · 1992–2026

BOOK 2,314 reports
RANK #465 of 1000
DEATH 1 death-typed
INJ 1,989 injury-typed
MALF 233 malfunction
SPAN 1992–2026
PEAK 2009: 312
PHOTO Choledochoscope And A…

Nearest event-volume peer: Choledochoscope And Accessories, Flexible/Rigid (14 report gap)

Prosthesis, Knee, Hemi-, Femoral sits #465 of 1000 among tracked device types with 2,314 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 → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Prosthesis, Knee, Hemi-, Femoral carries 86.0% INJURY-coded reports, 55.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
INJ 86.0% corpus 30.3% · above corpus mean (+55.7 pp)
MALF 10.1% corpus 64.8% · below corpus mean (-54.8 pp)

Lead product-problem code Explanted is 29% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 67% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Circuit

2,347
Light Source

2,332
Catheter

2,330
Prosthesis (this)

2,314
Choledochosco…

2,300
Pulmonary Val…

2,280

What this shows Prosthesis, Knee, Hemi-, Femoral carries 2,314 MAUDE reports, ranked #465 of 1000.

Event Types

Injury 1,989 (86.0%)

Malfunction 233 (10.1%)

Other 75 (3.2%)

16 (0.7%)

Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 1,176 (38.0%)

Hospitalization 758 (24.5%)

R 723 (23.3%)

239 (7.7%)

Other 131 (4.2%)

O 45 (1.5%)

S 10 (0.3%)

Disability 9 (0.3%)

H 3 (0.1%)

Life Threatening 2 (0.1%)

L 1 (0.0%)

Death 1 (0.0%)

Yearly Trend

1992: 1

1993: 6

1994: 10

1995: 8

1996: 22

1997: 72

1998: 86

1999: 45

2000: 34

2001: 25

2002: 32

2003: 64

2004: 258

2005: 202

2006: 269

2007: 199

2008: 288

2009: 312

2010: 243

2011: 42

2012: 31

2013: 30

2014: 13

2015: 11

2016: 1

2017: 3

2022: 4

2025: 2

2026: 1

Reports fell to 2 in 2025, down from an average of 4 in the two years before.

Top Manufacturers

DEPUY ORTHOPAEDICS, INC. 662

ZIMMER, INC. 242

STRYKER ORTHOPAEDICS MAHWAH 40

WRIGHT MEDICAL TECHNOLOGY, INC. 38

Event Locations

1,371 (59.2%)

HOSPITAL 881 (38.1%)

HOME 15 (0.6%)

INVALID DATA 11 (0.5%)

UNKNOWN 11 (0.5%)

NOT APPLICABLE 8 (0.3%)

OTHER 8 (0.3%)

I 5 (0.2%)

NO INFORMATION 2 (0.1%)

OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)

Compare DEPUY ORTHOPAEDICS, INC. vs ZIMMER, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Knee, Hemi-, Femoral: 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 (2,314 here).

Choledochoscope And Accessories 2,300 Catheter, Intravascular Occluding, Temporary 2,330 Light Source, Endoscope, Xenon Arc 2,332 Circuit, Breathing 2,347

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Prosthesis, Knee, Hemi-, Femoral 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, Knee, Hemi-, Femoral; 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.

Prosthesis, Knee, Hemi-, Femoral

Injury-coded reports run above the device-type norm