2026 data FDA MAUDE openFDA FDA Class III

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

#119 of 1000 · 25,951 reports · 2004–2026

  • BOOK 25,951 reports
  • RANK #119 of 1000
  • DEATH 7 death-typed
  • INJ 25,112 injury-typed
  • MALF 821 malfunction
  • SPAN 2004–2026
  • PEAK 2021: 2,644
  • PHOTO Tubes

Nearest event-volume peer: Tubes, Gastrointestinal (And Accessories) (121 report gap)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing sits #119 of 1000 among tracked device types with 25,951 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 →

Injury-coded reports run above the device-type norm

Prosthesis carries 96.8% INJURY-coded reports, 66.5pp 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 96.8% corpus 30.3% · above corpus mean (+66.5 pp)
  • MALF 3.2% corpus 64.8% · below corpus mean (-61.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 36% of manufacturer-tagged reports · Top event location is 61% 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 25,951 MAUDE reports, ranked #119 of 1000.

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

Event Types

Injury 25,112 (96.8%)
Malfunction 821 (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 24,371 (93.0%)
966 (3.7%)
Other 336 (1.3%)
R 256 (1.0%)
Hospitalization 210 (0.8%)
H 14 (0.1%)
O 11 (0.0%)
S 11 (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 9,352
Insufficient Device Problem Information 5,144
Loss of or Failure to Bond 4,777
Implant, removal of 1,828
Naturally Worn 1,504
Loose 584
Unknown (for use when the device problem is not known) 564
Appropriate Device Problem Term/Code Not Available 508
Migration or Expulsion of Device 500
Loss of Osseointegration 444
Migration 415
Component(s), worn 358
Loose or Intermittent Connection 287
Malposition of Device 265
Unintended Movement 246
Device Dislodged or Dislocated 241
Osseointegration Problem 232
Fracture 230
Break 212
Other (for use when an appropriate device code cannot be identified) 207

Yearly Trend

04
2004: 2
05
2005: 5
06
2006: 16
07
2007: 369
08
2008: 688
09
2009: 808
10
2010: 1,008
11
2011: 1,089
12
2012: 1,306
13
2013: 1,297
14
2014: 1,299
15
2015: 1,067
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: 476

Reports in 2025 (1,102) held close to the prior two-year average of 1,415.

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

Event Locations

15,709 (60.5%)
I 10,202 (39.3%)
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 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 (25,951 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.