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

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

The FDA MAUDE database aggregates 3,870 adverse-event reports for Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) spanning the period from 1992 through 2026. Of these, 7 are classified as death reports, 3,796 as injury reports, and 47 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 10 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Insufficient Information topping the list at 818 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 519 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 7 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

3,870
Total Reports
7
Death Reports
3,796
Injury Reports
47
Malfunctions

Event Types

Injury 3,796 (98.1%)
Malfunction 47 (1.2%)
17 (0.4%)
Death 7 (0.2%)
Other 3 (0.1%)

Patient Outcomes

Required Intervention 3,195 (72.7%)
Hospitalization 506 (11.5%)
R 503 (11.4%)
84 (1.9%)
Other 73 (1.7%)
H 9 (0.2%)
O 9 (0.2%)
Death 9 (0.2%)
S 4 (0.1%)
Disability 3 (0.1%)

Top Product Problems

Insufficient Information 818
Corroded 103
Device Dislodged or Dislocated 98
Material Disintegration 51
Break 37
Appropriate Term/Code Not Available 28
Loose or Intermittent Connection 28
Naturally Worn 25
Material Erosion 24
Adverse Event Without Identified Device or Use Problem 20
Noise, Audible 19
Detachment of Device or Device Component 18
Fracture 16
Unstable 16
Loss of Osseointegration 14
Metal Shedding Debris 10
Malposition of Device 9
Migration or Expulsion of Device 9
Patient-Device Incompatibility 7
Device Slipped 5

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: 338
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: 17
26
2026: 1

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

Event Locations

HOSPITAL 1,896 (49.0%)
I 1,069 (27.6%)
888 (22.9%)
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. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.