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2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

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 LIGHT-BOOK · MAUDE

#268 of 1000 · 6,886 reports · 2004–2026

  • BOOK 6,886 reports
  • RANK #268 of 1000
  • DEATH 18 death-typed
  • INJ 6,577 injury-typed
  • MALF 118 malfunction
  • SPAN 2004–2026
  • PEAK 2014: 700
  • PHOTO Transcatheter Septal…

Nearest event-volume peer: Transcatheter Septal Occluder (2 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing sits #268 of 1000 among tracked device types with 6,886 MAUDE reports spanning 2004–2026. 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 95.5% INJURY-coded reports, 65.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 95.5% corpus 30.3% · above corpus mean (+65.2 pp)
  • MALF 1.7% corpus 64.8% · below corpus mean (-63.1 pp)

Lead product-problem code Insufficient Device Problem Information is 29% of coded problems · Lead manufacturer SMITH & NEPHEW ORTHOPAEDICS LTD accounts for 82% of manufacturer-tagged reports · Top event location is 58% 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, Metal/Metal, Resurfacing carries 6,886 MAUDE reports, ranked #268 of 1000.

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

Event Types

Injury 6,577 (95.5%)
136 (2.0%)
Malfunction 118 (1.7%)
Other 37 (0.5%)
Death 18 (0.3%)

Patient Outcomes

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

Hospitalization 5,509 (42.5%)
R 5,447 (42.0%)
Required Intervention 789 (6.1%)
H 301 (2.3%)
281 (2.2%)
O 266 (2.1%)
Other 259 (2.0%)
S 54 (0.4%)
Death 17 (0.1%)
L 13 (0.1%)
Life Threatening 12 (0.1%)
Disability 9 (0.1%)
D 4 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Insufficient Device Problem Information 2,438
Adverse Event Without Identified Device or Use Problem 1,670
Appropriate Device Problem Term/Code Not Available 1,129
Biocompatibility 801
Patient Device Interaction Problem 441
Metal Shedding Debris 306
Device Operates Differently Than Expected 234
Patient-Device Incompatibility 207
Device Slipped 175
Fracture 156
Device Dislodged or Dislocated 124
Noise, Audible 106
Break 105
Loose or Intermittent Connection 94
Compatibility Problem 85
Material Integrity Problem 70
Loosening of Implant Not Related to Bone-Ingrowth 66
Malposition of Device 65
Naturally Worn 61
Explanted 57

Yearly Trend

04
2004: 1
05
2005: 3
06
2006: 5
07
2007: 14
08
2008: 9
09
2009: 137
10
2010: 259
11
2011: 422
12
2012: 502
13
2013: 699
14
2014: 700
15
2015: 363
16
2016: 358
17
2017: 460
18
2018: 579
19
2019: 468
20
2020: 534
21
2021: 528
22
2022: 425
23
2023: 143
24
2024: 159
25
2025: 93
26
2026: 25

Reports fell to 93 in 2025, down from an average of 151 in the two years before.

Related Entities for Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Top Manufacturers

SMITH & NEPHEW ORTHOPAEDICS LTD 4,881
SMITH & NEPHEW ORTHOPAEDICS, LTD. 848
SMITH & NEPHEW ORTHOPAEDICS LTD. 174
SMITH & NEPHEW, INC. 50

Event Locations

3,985 (57.9%)
I 2,812 (40.8%)
HOSPITAL 43 (0.6%)
NO INFORMATION 41 (0.6%)
HOME 3 (0.0%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare SMITH & NEPHEW ORTHOPAEDICS LTD 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.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,886 here).

Transcatheter Septal Occluder 6,884 Pad, Heating, Powered 6,878 Continuous, Ventilator, Home Use 6,912 Device, Monitoring, Intracranial Pressure 6,841

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Adaptor 18 Agent, Occluding, Vascular, Permanent 18 Agents 18 Prosthesis 18

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.