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2026 data FDA MAUDE openFDA

Prosthesis, Knee, Patellofemorotibial, 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.

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FDA MAUDE casebook

openFDA event book Prosthesis HEAVY-BOOK · MAUDE

#25 of 1000 · 153,958 reports · 1992–2026

  • BOOK 153,958 reports
  • RANK #25 of 1000
  • DEATH 259 death-typed
  • INJ 129,193 injury-typed
  • MALF 22,841 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 14,987
  • PHOTO Ventricular Bypass

Nearest event-volume peer: Ventricular (Assist) Bypass (593 report gap)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer sits #25 of 1000 among tracked device types with 153,958 MAUDE reports spanning 1992–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 83.9% corpus 30.4% · above corpus mean (+53.5 pp)
  • MALF 14.8% corpus 64.5% · below corpus mean (-49.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 22% of manufacturer-tagged reports · Top event location is 49% 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/Metal/Polymer carries 153,958 MAUDE reports, ranked #25 of 1000.

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

Event Types

Injury 129,193 (83.9%)
Malfunction 22,841 (14.8%)
Other 1,372 (0.9%)
293 (0.2%)
Death 259 (0.2%)

Patient Outcomes

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

Required Intervention 86,982 (45.6%)
Hospitalization 29,619 (15.5%)
R 29,341 (15.4%)
22,346 (11.7%)
Other 14,118 (7.4%)
H 4,969 (2.6%)
O 1,528 (0.8%)
S 860 (0.5%)
Disability 365 (0.2%)
Death 285 (0.1%)
Life Threatening 92 (0.0%)
L 78 (0.0%)
Congenital Anomaly 36 (0.0%)
D 12 (0.0%)
Invalid Data 4 (0.0%)
C 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 35,809
Insufficient Information 16,914
Fracture 10,050
Naturally Worn 7,736
Loss of or Failure to Bond 6,950
Loosening of Implant Not Related to Bone-Ingrowth 5,893
Unstable 4,909
Break 4,412
Appropriate Term/Code Not Available 4,173
Loose or Intermittent Connection 2,023
Device Dislodged or Dislocated 1,788
Migration or Expulsion of Device 1,776
Detachment of Device or Device Component 1,768
Migration 1,276
Noise, Audible 1,093
Difficult to Insert 886
Malposition of Device 813
Component Missing 808
Loss of Osseointegration 806
Device Appears to Trigger Rejection 740

Yearly Trend

92
1992: 15
93
1993: 126
94
1994: 114
95
1995: 139
96
1996: 182
97
1997: 218
98
1998: 193
99
1999: 195
00
2000: 279
01
2001: 360
02
2002: 520
03
2003: 551
04
2004: 986
05
2005: 1,141
06
2006: 1,414
07
2007: 1,305
08
2008: 1,483
09
2009: 1,870
10
2010: 3,286
11
2011: 5,134
12
2012: 5,202
13
2013: 6,136
14
2014: 6,722
15
2015: 6,881
16
2016: 7,586
17
2017: 12,263
18
2018: 14,040
19
2019: 14,987
20
2020: 12,592
21
2021: 9,408
22
2022: 8,363
23
2023: 8,947
24
2024: 10,828
25
2025: 9,418
26
2026: 1,074

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

Top Manufacturers

ZIMMER BIOMET, INC. 23,336
DEPUY ORTHOPAEDICS INC US 15,142
SMITH & NEPHEW, INC. 12,750
DEPUY IRELAND - 9616671 12,612
EXACTECH, INC. 10,682
ZIMMER, INC. 8,610
DEPUY ORTHOPAEDICS, INC. 7,077
BIOMET ORTHOPEDICS 5,522
STRYKER ORTHOPAEDICS-MAHWAH 5,278
DEPUY ORTHOPAEDICS, INC. 1818910 4,123

Event Locations

74,957 (48.7%)
I 71,097 (46.2%)
HOSPITAL 7,162 (4.7%)
NO INFORMATION 442 (0.3%)
UNKNOWN 80 (0.1%)
INVALID DATA 77 (0.1%)
HOME 70 (0.0%)
OTHER 50 (0.0%)
NOT APPLICABLE 9 (0.0%)
OUTPATIENT TREATMENT FACILITY 7 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
PARK 1 (0.0%)

Compare ZIMMER BIOMET, INC. vs DEPUY ORTHOPAEDICS INC US →

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 (153,958 here).

Ventricular Bypass 153,365 Implantable Pulse Generator, Pacemaker 147,576 Integrated Continuous Glucose Monitoring Sy… 146,937 System, Peritoneal, Automatic Delivery 163,240

Similar death-typed counts

Nearest other device types by death-typed report count (259 here), distinct from the volume row.

Laparoscope, General & Plastic Surgery 257 Separator, Automated, Blood Cell, Diagnostic 261 Console 256 Mesh 256

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.