2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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 III (highest risk, premarket approval required), regulated under 21 CFR §888.3330 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis, Hip, Semi-Constrained HEAVY-BOOK · MAUDE

#30 of 1000 · 138,399 reports · 1992–2026

  • BOOK 138,399 reports
  • RANK #30 of 1000
  • DEATH 387 death-typed
  • INJ 130,623 injury-typed
  • MALF 4,669 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 24,766
  • PHOTO System

Nearest event-volume peer: System, Surgical, Computer Controlled Instrument (419 report gap)

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) sits #30 of 1000 among tracked device types with 138,399 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, Hip, Semi-Constrained carries 94.4% INJURY-coded reports, 64.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 94.4% corpus 30.3% · above corpus mean (+64.1 pp)
  • MALF 3.4% corpus 64.8% · below corpus mean (-61.5 pp)

Lead product-problem code Insufficient Device Problem Information is 45% of coded problems · Lead manufacturer DEPUY INTERNATIONAL accounts for 25% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Prosthesis, Hip, Semi-Constrained 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 Uncemented Acetabular Component) carries 138,399 MAUDE reports, ranked #30 of 1000.

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

Event Types

Injury 130,623 (94.4%)
Malfunction 4,669 (3.4%)
Other 2,303 (1.7%)
417 (0.3%)
Death 387 (0.3%)

Patient Outcomes

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

Required Intervention 86,300 (52.9%)
Other 24,666 (15.1%)
R 22,621 (13.9%)
Hospitalization 21,767 (13.3%)
4,868 (3.0%)
O 995 (0.6%)
H 796 (0.5%)
Death 542 (0.3%)
S 412 (0.3%)
Life Threatening 89 (0.1%)
Disability 66 (0.0%)
L 46 (0.0%)
D 26 (0.0%)
Congenital Anomaly 20 (0.0%)

Top Product Problems

Insufficient Device Problem Information 72,117
Adverse Event Without Identified Device or Use Problem 16,179
Appropriate Device Problem Term/Code Not Available 12,114
Metal Shedding Debris 10,526
Naturally Worn 9,249
Device Dislodged or Dislocated 7,225
Loss of Osseointegration 7,127
Noise, Audible 4,492
Nonstandard Device 2,844
Corroded 2,817
Malposition of Device 1,974
Material Erosion 1,858
Material Disintegration 1,797
Fracture 1,731
Loose or Intermittent Connection 1,688
Loss of or Failure to Bond 1,687
Implant, removal of 1,627
Device Slipped 1,565
Migration or Expulsion of Device 1,410
Device Operates Differently Than Expected 1,360

Yearly Trend

92
1992: 1
94
1994: 23
95
1995: 2
96
1996: 1
97
1997: 1
98
1998: 4
99
1999: 1
00
2000: 6
01
2001: 10
02
2002: 17
03
2003: 11
04
2004: 32
05
2005: 81
06
2006: 150
07
2007: 215
08
2008: 757
09
2009: 818
10
2010: 3,347
11
2011: 17,832
12
2012: 24,766
13
2013: 20,017
14
2014: 16,491
15
2015: 12,340
16
2016: 7,874
17
2017: 6,846
18
2018: 6,388
19
2019: 7,628
20
2020: 4,538
21
2021: 2,064
22
2022: 1,617
23
2023: 1,475
24
2024: 1,168
25
2025: 1,228
26
2026: 650

Reports in 2025 (1,228) held close to the prior two-year average of 1,322.

Related Entities for Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Event Locations

79,344 (57.3%)
I 54,590 (39.4%)
HOSPITAL 4,206 (3.0%)
NO INFORMATION 224 (0.2%)
OTHER 16 (0.0%)
HOME 10 (0.0%)
NURSING HOME 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
INVALID DATA 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare DEPUY INTERNATIONAL vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Hip, Semi-Constrained: 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 (138,399 here).

Similar death-typed counts

Nearest other device types by death-typed report count (387 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Hip, Semi-Constrained 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, Hip, Semi-Constrained; 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.