2025 data FDA MAUDE openFDA

Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

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

#428 of 1000 · 2,621 reports · 1994–2025

  • BOOK 2,621 reports
  • RANK #428 of 1000
  • DEATH 4 death-typed
  • INJ 2,516 injury-typed
  • MALF 88 malfunction
  • SPAN 1994–2025
  • PEAK 2019: 354
  • PHOTO Bur

Nearest event-volume peer: Bur, Ear, Nose And Throat (8 report gap)

Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal sits #428 of 1000 among tracked device types with 2,621 MAUDE reports spanning 1994–2025. 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 96.0% corpus 30.4% · above corpus mean (+65.6 pp)
  • MALF 3.4% corpus 64.5% · below corpus mean (-61.1 pp)

Lead product-problem code Insufficient Information is 30% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 94% of manufacturer-tagged reports · Top event location is 50% 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, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal carries 2,621 MAUDE reports, ranked #428 of 1000.

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

Event Types

Injury 2,516 (96.0%)
Malfunction 88 (3.4%)
12 (0.5%)
Death 4 (0.2%)
Other 1 (0.0%)

Patient Outcomes

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

Hospitalization 1,941 (43.9%)
R 1,646 (37.2%)
Required Intervention 388 (8.8%)
155 (3.5%)
O 133 (3.0%)
Other 128 (2.9%)
H 22 (0.5%)
Death 5 (0.1%)
S 3 (0.1%)
Life Threatening 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Insufficient Information 385
Adverse Event Without Identified Device or Use Problem 293
Device Dislodged or Dislocated 132
Break 85
Fracture 79
Loosening of Implant Not Related to Bone-Ingrowth 50
Naturally Worn 47
Loose or Intermittent Connection 42
Appropriate Term/Code Not Available 31
Unintended Movement 22
Biocompatibility 20
Corroded 15
Unstable 15
Degraded 11
Migration or Expulsion of Device 10
Material Deformation 9
Detachment Of Device Component 8
Compatibility Problem 7
Loss of Osseointegration 7
Material Integrity Problem 7

Yearly Trend

94
1994: 2
95
1995: 2
97
1997: 3
99
1999: 2
00
2000: 3
01
2001: 11
02
2002: 7
03
2003: 4
05
2005: 5
06
2006: 2
07
2007: 4
08
2008: 1
09
2009: 91
10
2010: 130
11
2011: 147
12
2012: 230
13
2013: 243
14
2014: 323
15
2015: 121
16
2016: 94
17
2017: 82
18
2018: 223
19
2019: 354
20
2020: 292
21
2021: 158
22
2022: 75
23
2023: 5
24
2024: 6
25
2025: 1

Related Entities for Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

Event Locations

1,318 (50.3%)
I 1,279 (48.8%)
HOSPITAL 23 (0.9%)
INVALID DATA 1 (0.0%)

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

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 (2,621 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 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.