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Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Open-data reference.

FDA MAUDE adverse event data · 1999–2026

What the Data Shows About Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

The FDA MAUDE database aggregates 5,290 adverse-event reports for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented spanning the period from 1999 through 2026. Of these, 10 are classified as death reports, 3,106 as injury reports, and 2,141 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 13 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 Break topping the list at 1,373 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 27 years of MAUDE data, with the peak single-year volume reaching 696 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 8 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.

5,290
Total Reports
10
Death Reports
3,106
Injury Reports
2,141
Malfunctions

Event Types

Injury 3,106 (58.7%)
Malfunction 2,141 (40.5%)
Other 25 (0.5%)
Death 10 (0.2%)
8 (0.2%)

Patient Outcomes

Required Intervention 2,246 (36.9%)
2,000 (32.9%)
R 665 (10.9%)
Hospitalization 623 (10.2%)
Other 402 (6.6%)
O 77 (1.3%)
H 42 (0.7%)
Death 11 (0.2%)
S 10 (0.2%)
Disability 5 (0.1%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 1,373
Fracture 418
Insufficient Information 320
Adverse Event Without Identified Device or Use Problem 316
Device Dislodged or Dislocated 149
Noise, Audible 104
Appropriate Term/Code Not Available 91
Crack 65
Naturally Worn 63
Material Twisted/Bent 57
Loss of Osseointegration 56
Material Deformation 43
Osseointegration Problem 35
Malposition of Device 34
Loose or Intermittent Connection 33
Loosening of Implant Not Related to Bone-Ingrowth 31
Scratched Material 25
Degraded 24
Device-Device Incompatibility 23
Migration or Expulsion of Device 23

Yearly Trend

99
1999: 1
00
2000: 2
02
2002: 2
03
2003: 22
04
2004: 25
05
2005: 65
06
2006: 89
07
2007: 117
08
2008: 146
09
2009: 91
10
2010: 186
11
2011: 248
12
2012: 283
13
2013: 235
14
2014: 281
15
2015: 330
16
2016: 367
17
2017: 540
18
2018: 696
19
2019: 641
20
2020: 371
21
2021: 109
22
2022: 89
23
2023: 132
24
2024: 118
25
2025: 92
26
2026: 12

Related Entities for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Event Locations

I 2,916 (55.1%)
1,995 (37.7%)
HOSPITAL 370 (7.0%)
NO INFORMATION 3 (0.1%)
OTHER 2 (0.0%)
UNKNOWN 2 (0.0%)
HOME 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. 1818910 →

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.