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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3565 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#167 of 1000 · 16,332 reports · 2003–2026

  • BOOK 16,332 reports
  • RANK #167 of 1000
  • DEATH 11 death-typed
  • INJ 12,364 injury-typed
  • MALF 3,929 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 1,576
  • PHOTO Endoscopic Ultrasound…

Nearest event-volume peer: Endoscopic Ultrasound System, Gastroenterology-Urology (1 report gap)

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer sits #167 of 1000 among tracked device types with 16,332 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 →

Injury-coded reports run above the device-type norm

Prosthesis carries 75.7% INJURY-coded reports, 45.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 75.7% corpus 30.3% · above corpus mean (+45.4 pp)
  • MALF 24.1% corpus 64.8% · below corpus mean (-40.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 54% of manufacturer-tagged reports · Top event location is 52% 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 16,332 MAUDE reports, ranked #167 of 1000.

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

Event Types

Injury 12,364 (75.7%)
Malfunction 3,929 (24.1%)
Other 20 (0.1%)
Death 11 (0.1%)
8 (0.0%)

Patient Outcomes

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

Hospitalization 5,517 (23.2%)
R 5,510 (23.1%)
Required Intervention 4,804 (20.2%)
Other 2,965 (12.4%)
2,951 (12.4%)
H 1,772 (7.4%)
O 225 (0.9%)
S 26 (0.1%)
Life Threatening 18 (0.1%)
Disability 17 (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 4,300
Insufficient Device Problem Information 3,157
Fracture 1,608
Unstable 1,500
Break 901
Loss of Osseointegration 554
Loosening of Implant Not Related to Bone-Ingrowth 389
Osseointegration Problem 362
Difficult to Insert 352
Detachment of Device or Device Component 349
Naturally Worn 326
Appropriate Device Problem Term/Code Not Available 270
Device Dislodged or Dislocated 258
Loose or Intermittent Connection 257
Mechanical Problem 252
Malposition of Device 249
Device Operates Differently Than Expected 245
Degraded 221
Material Integrity Problem 211
Noise, Audible 202

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: 371
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: 1,576
26
2026: 939

Reports in 2025 (1,576) held close to the prior two-year average of 1,380.

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

Top Manufacturers

STRYKER ORTHOPAEDICS-MAHWAH 7,087
ZIMMER BIOMET, INC. 2,856
SMITH & NEPHEW, INC. 1,013
ZIMMER, INC. 720
BIOMET ORTHOPEDICS 447
DEPUY IRELAND - 9616671 359
ZIMMER MANUFACTURING B.V. 285
DEPUY ORTHOPAEDICS INC US 208
DEPUY IRELAND - 3015516266 195

Event Locations

8,542 (52.3%)
I 7,655 (46.9%)
HOSPITAL 101 (0.6%)
NO INFORMATION 33 (0.2%)
OTHER 1 (0.0%)

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

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 (16,332 here).

Endoscopic Ultrasound System 16,331 Catheter, Urological And Accessories 16,326 Cardiac Ablation Percutaneous Catheter 16,442 Prosthesis 16,505

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Cabinet, Table And Tray, Anesthesia 11 Circuit, Breathing 11 Collector 11 Condenser, Heat And Moisture 11

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

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.