2026 data FDA MAUDE openFDA

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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

#166 of 1000 · 15,610 reports · 2003–2026

  • BOOK 15,610 reports
  • RANK #166 of 1000
  • DEATH 11 death-typed
  • INJ 11,794 injury-typed
  • MALF 3,777 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 1,574
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Urological (Antimicrobial) And Accessories (6 report gap)

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer sits #166 of 1000 among tracked device types with 15,610 MAUDE reports spanning 2003–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 75.6% corpus 30.4% · above corpus mean (+45.1 pp)
  • MALF 24.2% corpus 64.5% · below corpus mean (-40.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 55% of manufacturer-tagged reports · Top event location is 50% 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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer carries 15,610 MAUDE reports, ranked #166 of 1000.

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

Event Types

Injury 11,794 (75.6%)
Malfunction 3,777 (24.2%)
Other 20 (0.1%)
Death 11 (0.1%)
8 (0.1%)

Patient Outcomes

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

Hospitalization 5,347 (23.5%)
R 5,343 (23.5%)
Required Intervention 4,504 (19.8%)
Other 2,882 (12.7%)
2,798 (12.3%)
H 1,604 (7.0%)
O 217 (1.0%)
S 24 (0.1%)
Life Threatening 18 (0.1%)
Disability 15 (0.1%)
Death 13 (0.1%)
L 4 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,737
Insufficient Information 2,428
Fracture 1,363
Unstable 1,332
Break 677
Loss of Osseointegration 503
Loosening of Implant Not Related to Bone-Ingrowth 336
Osseointegration Problem 333
Detachment of Device or Device Component 305
Naturally Worn 275
Difficult to Insert 266
Malposition of Device 209
Mechanical Problem 193
Degraded 191
Migration 186
Device Dislodged or Dislocated 185
Noise, Audible 180
Migration or Expulsion of Device 145
Loose or Intermittent Connection 130
Appropriate Term/Code Not Available 126

Yearly Trend

03
2003: 1
04
2004: 5
05
2005: 7
06
2006: 5
07
2007: 27
08
2008: 21
09
2009: 89
10
2010: 121
11
2011: 247
12
2012: 370
13
2013: 308
14
2014: 385
15
2015: 955
16
2016: 1,034
17
2017: 1,007
18
2018: 1,191
19
2019: 1,394
20
2020: 1,089
21
2021: 1,539
22
2022: 1,261
23
2023: 1,263
24
2024: 1,497
25
2025: 1,574
26
2026: 220

Related Entities for Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Event Locations

7,819 (50.1%)
I 7,657 (49.1%)
HOSPITAL 100 (0.6%)
NO INFORMATION 33 (0.2%)
OTHER 1 (0.0%)

Compare STRYKER ORTHOPAEDICS-MAHWAH vs ZIMMER BIOMET, INC. →

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 (15,610 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 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.