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2026 data FDA MAUDE openFDA FDA Class III

Prosthesis, Hip, Semi-Constrained (Metal Cemented 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 §888.3320 (Orthopedic panel).

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FDA MAUDE casebook

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

#358 of 1000 · 3,885 reports · 1992–2026

  • BOOK 3,885 reports
  • RANK #358 of 1000
  • DEATH 7 death-typed
  • INJ 3,811 injury-typed
  • MALF 47 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 519
  • PHOTO Transducer

Nearest event-volume peer: Transducer, Blood-Pressure, Extravascular (19 report gap)

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) sits #358 of 1000 among tracked device types with 3,885 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 98.1% INJURY-coded reports, 67.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 98.1% corpus 30.3% · above corpus mean (+67.8 pp)
  • MALF 1.2% corpus 64.8% · below corpus mean (-63.6 pp)

Lead product-problem code Insufficient Device Problem Information is 42% of coded problems · Lead manufacturer MICROPORT ORTHOPEDICS INC. accounts for 55% of manufacturer-tagged reports · Top event location HOSPITAL is 49% 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 Cemented Acetabular Component) carries 3,885 MAUDE reports, ranked #358 of 1000.

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

Event Types

Injury 3,811 (98.1%)
Malfunction 47 (1.2%)
17 (0.4%)
Death 7 (0.2%)
Other 3 (0.1%)

Patient Outcomes

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

Required Intervention 3,205 (72.6%)
R 506 (11.5%)
Hospitalization 506 (11.5%)
84 (1.9%)
Other 74 (1.7%)
O 11 (0.2%)
H 9 (0.2%)
Death 9 (0.2%)
S 5 (0.1%)
Disability 5 (0.1%)

Top Product Problems

Insufficient Device Problem Information 1,718
Adverse Event Without Identified Device or Use Problem 475
Naturally Worn 297
Device Dislodged or Dislocated 222
Implant, removal of 195
Metal Shedding Debris 164
Corroded 150
Component(s), worn 135
Appropriate Device Problem Term/Code Not Available 105
Loose or Intermittent Connection 86
Unknown (for use when the device problem is not known) 69
Break 68
Loss of Osseointegration 66
Explanted 59
Fracture 56
Noise, Audible 56
Material Disintegration 53
Device Operates Differently Than Expected 47
Device Slipped 43
Malposition of Device 42

Yearly Trend

92
1992: 4
93
1993: 4
94
1994: 6
99
1999: 5
00
2000: 6
01
2001: 5
02
2002: 7
03
2003: 6
04
2004: 7
05
2005: 9
06
2006: 5
07
2007: 79
08
2008: 67
09
2009: 104
10
2010: 198
11
2011: 271
12
2012: 339
13
2013: 496
14
2014: 519
15
2015: 466
16
2016: 299
17
2017: 336
18
2018: 205
19
2019: 140
20
2020: 94
21
2021: 68
22
2022: 49
23
2023: 32
24
2024: 27
25
2025: 16
26
2026: 16

Reports fell to 16 in 2025, down from an average of 30 in the two years before.

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

Top Manufacturers

MICROPORT ORTHOPEDICS INC. 1,958
WRIGHT MEDICAL TECHNOLOGY, INC. 944
DEPUY ORTHOPAEDICS, INC. 378
BIOMET ORTHOPEDICS 102
DEPUY WARSAW 69
ZIMMER BIOMET, INC. 50
STRYKER ORTHOPAEDICS-MAHWAH 20
1818910 DEPUY ORTHOPAEDICS, INC. 19

Event Locations

HOSPITAL 1,897 (48.8%)
I 1,069 (27.5%)
902 (23.2%)
HOME 6 (0.2%)
NO INFORMATION 5 (0.1%)
OTHER 4 (0.1%)
INVALID DATA 2 (0.1%)

Compare MICROPORT ORTHOPEDICS INC. vs WRIGHT MEDICAL TECHNOLOGY, INC. →

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 (3,885 here).

Transducer, Blood-Pressure, Extravascular 3,904 Collector 3,860 File, Pulp Canal, Endodontic 3,925 Analyzer, Pacemaker Generator Function 3,843

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

Read our methodology - how this data is sourced, computed, and verified.

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.