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

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

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

The FDA MAUDE database aggregates 31,425 adverse-event reports for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented spanning the period from 1992 through 2026. Of these, 51 are classified as death reports, 28,278 as injury reports, and 2,817 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 14 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 Adverse Event Without Identified Device or Use Problem topping the list at 7,084 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 35 years of MAUDE data, with the peak single-year volume reaching 3,286 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 12 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.

31,425
Total Reports
51
Death Reports
28,278
Injury Reports
2,817
Malfunctions

Event Types

Injury 28,278 (90.0%)
Malfunction 2,817 (9.0%)
Other 208 (0.7%)
71 (0.2%)
Death 51 (0.2%)

Patient Outcomes

Required Intervention 17,458 (42.9%)
R 7,627 (18.7%)
Hospitalization 7,502 (18.4%)
Other 3,435 (8.4%)
2,665 (6.5%)
H 1,331 (3.3%)
O 431 (1.1%)
S 71 (0.2%)
Death 49 (0.1%)
Disability 43 (0.1%)
Life Threatening 38 (0.1%)
L 22 (0.1%)
Congenital Anomaly 10 (0.0%)
D 6 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 7,084
Device Dislodged or Dislocated 4,527
Insufficient Information 4,022
Fracture 1,598
Appropriate Term/Code Not Available 1,548
Naturally Worn 668
Osseointegration Problem 631
Break 538
Material Erosion 484
Loose or Intermittent Connection 470
Loosening of Implant Not Related to Bone-Ingrowth 401
Unstable 367
Corroded 341
Migration 316
Noise, Audible 298
Device Appears to Trigger Rejection 295
Loss of Osseointegration 247
Tear, Rip or Hole in Device Packaging 219
Migration or Expulsion of Device 191
Difficult to Insert 183

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 3
95
1995: 2
96
1996: 14
97
1997: 15
98
1998: 2
99
1999: 12
00
2000: 14
01
2001: 32
02
2002: 45
03
2003: 52
04
2004: 40
05
2005: 56
06
2006: 56
07
2007: 138
08
2008: 125
09
2009: 189
10
2010: 395
11
2011: 543
12
2012: 963
13
2013: 1,369
14
2014: 1,475
15
2015: 1,348
16
2016: 1,728
17
2017: 2,166
18
2018: 3,121
19
2019: 3,067
20
2020: 1,964
21
2021: 2,199
22
2022: 1,985
23
2023: 2,062
24
2024: 2,586
25
2025: 3,286
26
2026: 371

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

Event Locations

16,017 (51.0%)
I 14,332 (45.6%)
HOSPITAL 935 (3.0%)
NO INFORMATION 78 (0.2%)
HOME 32 (0.1%)
INVALID DATA 11 (0.0%)
UNKNOWN 8 (0.0%)
OTHER 6 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
NOT APPLICABLE 1 (0.0%)
NURSING HOME 1 (0.0%)
PATIENT'S HOME 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs MEDACTA INTERNATIONAL SA →

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.