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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

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 §888.3560 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#583 of 1000 · 1,423 reports · 2012–2026

  • BOOK 1,423 reports
  • RANK #583 of 1000
  • DEATH 0 death-typed
  • INJ 1,264 injury-typed
  • MALF 123 malfunction
  • SPAN 2012–2026
  • PEAK 2021: 379
  • PHOTO External Mandibular F…

Nearest event-volume peer: External Mandibular Fixator And/Or Distractor (7 report gap)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive sits #583 of 1000 among tracked device types with 1,423 MAUDE reports spanning 2012–2026. 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 88.8% INJURY-coded reports, 58.5pp 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 88.8% corpus 30.3% · above corpus mean (+58.5 pp)
  • MALF 8.6% corpus 64.8% · below corpus mean (-56.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 25% of manufacturer-tagged reports · Top event location I is 70% 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, Cemented, Polymer + Additive/Metal/Polymer + Additive carries 1,423 MAUDE reports, ranked #583 of 1000.

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

Event Types

Injury 1,264 (88.8%)
Malfunction 123 (8.6%)
Other 29 (2.0%)
7 (0.5%)

Patient Outcomes

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

Required Intervention 865 (48.4%)
R 286 (16.0%)
Other 231 (12.9%)
Hospitalization 184 (10.3%)
131 (7.3%)
O 60 (3.4%)
H 20 (1.1%)
Disability 5 (0.3%)
S 2 (0.1%)
L 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 474
Insufficient Device Problem Information 268
Unstable 159
Appropriate Device Problem Term/Code Not Available 147
Failure To Adhere Or Bond 104
Fracture 65
Loss of or Failure to Bond 33
Loose or Intermittent Connection 31
Difficult to Insert 26
Migration or Expulsion of Device 21
Device Operates Differently Than Expected 20
Naturally Worn 17
Device Dislodged or Dislocated 16
Noise, Audible 16
Break 14
Inadequacy of Device Shape and/or Size 14
Loosening of Implant Not Related to Bone-Ingrowth 14
Device Contaminated During Manufacture or Shipping 9
Patient Device Interaction Problem 9
Migration 8

Yearly Trend

12
2012: 6
13
2013: 16
14
2014: 84
15
2015: 282
16
2016: 130
17
2017: 91
18
2018: 64
19
2019: 78
20
2020: 121
21
2021: 379
22
2022: 42
23
2023: 40
24
2024: 34
25
2025: 37
26
2026: 19

Reports in 2025 (37) held close to the prior two-year average of 37.

Related Entities for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Top Manufacturers

DEPUY IRELAND - 9616671 312
ENCORE MEDICAL L.P. 213
ZIMMER, INC. 195
ENCORE MEDICAL, L.P. 192
ZIMMER BIOMET, INC. 176
ZIMMER INC 100
ENCORE MEDICAL L.P 56

Event Locations

I 992 (69.7%)
410 (28.8%)
NO INFORMATION 19 (1.3%)
HOSPITAL 2 (0.1%)

Compare DEPUY IRELAND - 9616671 vs ENCORE MEDICAL L.P. →

Nationwide devices with a comparable report-volume footprint

Prosthesis carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,423 here).

External Mandibular Fixator And/Or Distract… 1,416 Stimulator, Bone Growth, Non-Invasive 1,433 Locator, Root Apex 1,412 Unit, Operative Dental 1,407

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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.