2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

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 §888.3358 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#664 of 1000 · 1,004 reports · 1992–2026

  • BOOK 1,004 reports
  • RANK #664 of 1000
  • DEATH 1 death-typed
  • INJ 898 injury-typed
  • MALF 102 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 172
  • PHOTO Filter

Nearest event-volume peer: Filter, Bacterial, Breathing-Circuit (0 report gap)

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous sits #664 of 1000 among tracked device types with 1,004 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 →

Injury-coded reports run above the device-type norm

Prosthesis carries 89.4% INJURY-coded reports, 59.1pp 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 89.4% corpus 30.3% · above corpus mean (+59.1 pp)
  • MALF 10.2% corpus 64.8% · below corpus mean (-54.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 97% of manufacturer-tagged reports · Top event location I is 62% 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, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous carries 1,004 MAUDE reports, ranked #664 of 1000.

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

Event Types

Injury 898 (89.4%)
Malfunction 102 (10.2%)
2 (0.2%)
Death 1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

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

Hospitalization 565 (33.4%)
R 548 (32.4%)
Required Intervention 196 (11.6%)
117 (6.9%)
Other 107 (6.3%)
H 77 (4.6%)
O 65 (3.8%)
Life Threatening 5 (0.3%)
S 4 (0.2%)
Disability 3 (0.2%)
Death 2 (0.1%)
L 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 338
Insufficient Device Problem Information 191
Device Dislodged or Dislocated 127
Connection Problem 37
Loose or Intermittent Connection 36
Biocompatibility 25
Appropriate Device Problem Term/Code Not Available 24
Unintended Movement 22
Fitting Problem 21
Break 18
Unstable 18
Fracture 16
Loosening of Implant Not Related to Bone-Ingrowth 14
Malposition of Device 13
Device Slipped 12
Loss of Osseointegration 11
Migration 11
Osseointegration Problem 11
Incomplete or Inadequate Connection 10
Positioning Problem 10

Yearly Trend

92
1992: 1
93
1993: 1
98
1998: 1
10
2010: 1
11
2011: 6
12
2012: 3
13
2013: 5
14
2014: 15
15
2015: 55
16
2016: 54
17
2017: 61
18
2018: 112
19
2019: 172
20
2020: 115
21
2021: 116
22
2022: 90
23
2023: 78
24
2024: 54
25
2025: 43
26
2026: 21

Reports in 2025 (43) held close to the prior two-year average of 66.

Related Entities for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Event Locations

I 626 (62.4%)
368 (36.7%)
HOSPITAL 6 (0.6%)
NO INFORMATION 2 (0.2%)
OTHER 2 (0.2%)

Compare SMITH & NEPHEW, INC. vs SMITH & NEPHEW ORTHOPAEDICS LTD →

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.

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.