2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#571 of 1000 · 1,410 reports · 2012–2026

  • BOOK 1,410 reports
  • RANK #571 of 1000
  • DEATH 0 death-typed
  • INJ 1,251 injury-typed
  • MALF 123 malfunction
  • SPAN 2012–2026
  • PEAK 2021: 379
  • PHOTO Confocal Optical Imag…

Nearest event-volume peer: Confocal Optical Imaging (1 report gap)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive sits #571 of 1000 among tracked device types with 1,410 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 →

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 88.7% corpus 30.4% · above corpus mean (+58.3 pp)
  • MALF 8.7% corpus 64.5% · below corpus mean (-55.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 41% 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 1,410 MAUDE reports, ranked #571 of 1000.

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

Event Types

Injury 1,251 (88.7%)
Malfunction 123 (8.7%)
Other 29 (2.1%)
7 (0.5%)

Patient Outcomes

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

Required Intervention 853 (48.1%)
R 285 (16.1%)
Other 231 (13.0%)
Hospitalization 183 (10.3%)
131 (7.4%)
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 442
Unstable 121
Appropriate Term/Code Not Available 117
Insufficient Information 105
Fracture 63
Failure To Adhere Or Bond 32
Loss of or Failure to Bond 31
Difficult to Insert 22
Loose or Intermittent Connection 20
Naturally Worn 17
Migration or Expulsion of Device 16
Noise, Audible 15
Loosening of Implant Not Related to Bone-Ingrowth 13
Device Dislodged or Dislocated 12
Device Contaminated During Manufacture or Shipping 9
Migration 8
Patient Device Interaction Problem 8
Inadequacy of Device Shape and/or Size 7
Device Operates Differently Than Expected 5
Tear, Rip or Hole in Device Packaging 5

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: 6

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

Event Locations

I 993 (70.4%)
396 (28.1%)
NO INFORMATION 19 (1.3%)
HOSPITAL 2 (0.1%)

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

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 (1,410 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 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.