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Prosthesis, Hip, Femoral, Resurfacing

Open-data reference.

FDA MAUDE adverse event data · 1992–2025

What the Data Shows About Prosthesis, Hip, Femoral, Resurfacing

The FDA MAUDE database aggregates 12,475 adverse-event reports for Prosthesis, Hip, Femoral, Resurfacing spanning the period from 1992 through 2025. Of these, 40 are classified as death reports, 12,139 as injury reports, and 273 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 Insufficient Information topping the list at 949 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 2,522 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.

12,475
Total Reports
40
Death Reports
12,139
Injury Reports
273
Malfunctions

Event Types

Injury 12,139 (97.3%)
Malfunction 273 (2.2%)
Death 40 (0.3%)
17 (0.1%)
Other 6 (0.0%)

Patient Outcomes

Required Intervention 9,651 (73.5%)
Other 1,934 (14.7%)
R 572 (4.4%)
Hospitalization 494 (3.8%)
323 (2.5%)
Death 59 (0.4%)
S 49 (0.4%)
O 24 (0.2%)
Disability 8 (0.1%)
H 6 (0.0%)
Congenital Anomaly 4 (0.0%)
D 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Insufficient Information 949
Adverse Event Without Identified Device or Use Problem 753
Appropriate Term/Code Not Available 386
Device Dislodged or Dislocated 261
Loss of Osseointegration 185
Naturally Worn 158
Migration 153
Corroded 98
Noise, Audible 94
Fracture 65
Osseointegration Problem 50
Loss of or Failure to Bond 49
Degraded 47
Metal Shedding Debris 46
Nonstandard Device 29
Loose or Intermittent Connection 27
Material Erosion 27
Biocompatibility 26
Use of Device Problem 24
Malposition of Device 23

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 2
95
1995: 4
01
2001: 3
02
2002: 1
03
2003: 8
05
2005: 2
07
2007: 15
08
2008: 22
09
2009: 11
10
2010: 68
11
2011: 592
12
2012: 2,087
13
2013: 2,522
14
2014: 2,431
15
2015: 1,674
16
2016: 621
17
2017: 580
18
2018: 430
19
2019: 971
20
2020: 373
21
2021: 17
22
2022: 13
23
2023: 6
24
2024: 2
25
2025: 14

Related Entities for Prosthesis, Hip, Femoral, Resurfacing

Event Locations

7,426 (59.5%)
I 4,754 (38.1%)
HOSPITAL 274 (2.2%)
NO INFORMATION 13 (0.1%)
HOME 3 (0.0%)
INVALID DATA 2 (0.0%)
OTHER 2 (0.0%)
UNKNOWN 1 (0.0%)

Compare DEPUY INTERNATIONAL LTD. 8010379 vs DEPUY INTERNATIONAL →

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.