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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, 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 §888.3560 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#634 of 1000 · 1,136 reports · 2008–2026

  • BOOK 1,136 reports
  • RANK #634 of 1000
  • DEATH 0 death-typed
  • INJ 748 injury-typed
  • MALF 382 malfunction
  • SPAN 2008–2026
  • PEAK 2017: 150
  • PHOTO Pulmonic Valved Condu…

Nearest event-volume peer: Pulmonic Valved Conduit (3 report gap)

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer sits #634 of 1000 among tracked device types with 1,136 MAUDE reports spanning 2008–2026. 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 65.8% INJURY-coded reports, 35.6pp 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 65.8% corpus 30.3% · above corpus mean (+35.6 pp)
  • MALF 33.6% corpus 64.8% · below corpus mean (-31.2 pp)

Lead product-problem code Insufficient Device Problem Information is 27% of coded problems · Lead manufacturer MAKO SURGICAL CORP. accounts for 75% of manufacturer-tagged reports · Top event location I is 55% 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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer carries 1,136 MAUDE reports, ranked #634 of 1000.

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

Event Types

Injury 748 (65.8%)
Malfunction 382 (33.6%)
Other 5 (0.4%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 452 (31.2%)
Other 376 (25.9%)
R 240 (16.6%)
Hospitalization 231 (15.9%)
68 (4.7%)
H 58 (4.0%)
O 16 (1.1%)
Disability 9 (0.6%)

Top Product Problems

Insufficient Device Problem Information 329
Break 200
Adverse Event Without Identified Device or Use Problem 163
Fracture 116
Loss of Osseointegration 54
Appropriate Device Problem Term/Code Not Available 36
Difficult to Insert 34
Osseointegration Problem 28
Crack 27
Naturally Worn 27
Device Operates Differently Than Expected 26
Material Integrity Problem 26
Material Deformation 24
Degraded 23
Device Slipped 22
Loss of or Failure to Bond 20
Malposition of Device 17
Device Dislodged or Dislocated 16
Migration 15
Packaging Problem 14

Yearly Trend

08
2008: 1
09
2009: 3
10
2010: 13
11
2011: 32
12
2012: 72
13
2013: 98
14
2014: 75
15
2015: 55
16
2016: 93
17
2017: 150
18
2018: 141
19
2019: 91
20
2020: 65
21
2021: 51
22
2022: 32
23
2023: 52
24
2024: 44
25
2025: 49
26
2026: 19

Reports in 2025 (49) held close to the prior two-year average of 48.

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

Top Manufacturers

MAKO SURGICAL CORP. 620
STRYKER ORTHOPAEDICS-MAHWAH 115
DEPUY ORTHOPAEDICS INC US 86
DEPUY ORTHOPAEDICS, INC. 7

Event Locations

I 620 (54.6%)
502 (44.2%)
OTHER 11 (1.0%)
HOSPITAL 1 (0.1%)
NO INFORMATION 1 (0.1%)
NOT APPLICABLE 1 (0.1%)

Compare MAKO SURGICAL CORP. vs STRYKER ORTHOPAEDICS-MAHWAH →

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 (1,136 here).

Pulmonic Valved Conduit 1,133 Epidural Anesthesia Kit 1,130 Apparatus, Suction, Patient Care 1,122 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,120

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.