2026 data Public-data reference. official source

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Open-data reference.

FDA MAUDE adverse event data · 2004–2026

What the Data Shows About Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

The FDA MAUDE database aggregates 658 adverse-event reports for Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented spanning the period from 2004 through 2026. Of these, 0 are classified as death reports, 471 as injury reports, and 183 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 4 distinct event types and 9 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 Appropriate Term/Code Not Available topping the list at 137 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 15 years of MAUDE data, with the peak single-year volume reaching 178 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 5 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.

658
Total Reports
0
Death Reports
471
Injury Reports
183
Malfunctions

Event Types

Injury 471 (71.6%)
Malfunction 183 (27.8%)
Other 3 (0.5%)
1 (0.2%)

Patient Outcomes

Required Intervention 318 (39.8%)
135 (16.9%)
R 117 (14.7%)
Other 104 (13.0%)
Hospitalization 98 (12.3%)
O 13 (1.6%)
H 11 (1.4%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Appropriate Term/Code Not Available 137
Adverse Event Without Identified Device or Use Problem 110
Device Contaminated During Manufacture or Shipping 68
Device Dislodged or Dislocated 66
Insufficient Information 44
Unstable 25
Difficult to Insert 14
Fracture 14
Packaging Problem 14
Break 13
Patient Device Interaction Problem 10
Manufacturing, Packaging or Shipping Problem 9
Material Integrity Problem 9
Loosening of Implant Not Related to Bone-Ingrowth 8
Unintended Movement 8
Material Deformation 7
Loose or Intermittent Connection 6
Naturally Worn 6
Detachment of Device or Device Component 5
Difficult or Delayed Positioning 5

Yearly Trend

04
2004: 1
13
2013: 5
14
2014: 31
15
2015: 52
16
2016: 45
17
2017: 27
18
2018: 39
19
2019: 104
20
2020: 178
21
2021: 88
22
2022: 32
23
2023: 18
24
2024: 20
25
2025: 16
26
2026: 2

Related Entities for Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Event Locations

I 516 (78.4%)
137 (20.8%)
HOSPITAL 3 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
NO INFORMATION 1 (0.2%)

Compare ENCORE MEDICAL L.P. vs ZIMMER BIOMET, 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.