2026 data FDA MAUDE openFDA

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

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 MID-BOOK · MAUDE

#117 of 1000 · 25,649 reports · 2004–2026

  • BOOK 25,649 reports
  • RANK #117 of 1000
  • DEATH 7 death-typed
  • INJ 24,812 injury-typed
  • MALF 819 malfunction
  • SPAN 2004–2026
  • PEAK 2021: 2,644
  • PHOTO Wheelchair, Mechanical

Nearest event-volume peer: Wheelchair, Mechanical (15 report gap)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing sits #117 of 1000 among tracked device types with 25,649 MAUDE reports spanning 2004–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 96.7% corpus 30.4% · above corpus mean (+66.3 pp)
  • MALF 3.2% corpus 64.5% · below corpus mean (-61.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 52% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 35% of manufacturer-tagged reports · Top event location is 60% 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, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing carries 25,649 MAUDE reports, ranked #117 of 1000.

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

Event Types

Injury 24,812 (96.7%)
Malfunction 819 (3.2%)
7 (0.0%)
Death 7 (0.0%)
Other 4 (0.0%)

Patient Outcomes

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

Required Intervention 24,077 (93.0%)
964 (3.7%)
Other 336 (1.3%)
R 253 (1.0%)
Hospitalization 207 (0.8%)
H 12 (0.0%)
O 11 (0.0%)
S 10 (0.0%)
Death 10 (0.0%)
Disability 4 (0.0%)
Life Threatening 4 (0.0%)
D 3 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 9,094
Loss of or Failure to Bond 3,207
Insufficient Information 1,589
Naturally Worn 754
Migration 409
Unintended Movement 240
Osseointegration Problem 219
Appropriate Term/Code Not Available 214
Migration or Expulsion of Device 205
Device Dislodged or Dislocated 193
Loose or Intermittent Connection 191
Loss of Osseointegration 191
Fracture 168
Break 137
Device Contaminated During Manufacture or Shipping 109
Loosening of Implant Not Related to Bone-Ingrowth 106
Malposition of Device 105
Noise, Audible 96
Use of Device Problem 85
Difficult to Open or Remove Packaging Material 75

Yearly Trend

04
2004: 2
05
2005: 5
06
2006: 16
07
2007: 369
08
2008: 688
09
2009: 808
10
2010: 1,007
11
2011: 1,101
12
2012: 1,309
13
2013: 1,297
14
2014: 1,299
15
2015: 1,068
16
2016: 1,387
17
2017: 1,142
18
2018: 1,265
19
2019: 1,968
20
2020: 1,864
21
2021: 2,644
22
2022: 2,320
23
2023: 1,593
24
2024: 1,236
25
2025: 1,102
26
2026: 159

Related Entities for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Event Locations

15,400 (60.0%)
I 10,209 (39.8%)
NO INFORMATION 19 (0.1%)
HOSPITAL 18 (0.1%)
OTHER 3 (0.0%)

Compare DEPUY IRELAND - 9616671 vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (25,649 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 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.