2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Femoral, Resurfacing

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3400 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis, Hip, Femoral, Resurfacing MID-BOOK · MAUDE

#193 of 1000 · 12,333 reports · 1992–2026

  • BOOK 12,333 reports
  • RANK #193 of 1000
  • DEATH 40 death-typed
  • INJ 11,997 injury-typed
  • MALF 273 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 2,522
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (384 report gap)

Prosthesis, Hip, Femoral, Resurfacing sits #193 of 1000 among tracked device types with 12,333 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Prosthesis, Hip, Femoral, Resurfacing carries 97.3% INJURY-coded reports, 67.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 97.3% corpus 30.3% · above corpus mean (+67.0 pp)
  • MALF 2.2% corpus 64.8% · below corpus mean (-62.6 pp)

Lead product-problem code Insufficient Device Problem Information is 55% of coded problems · Lead manufacturer DEPUY INTERNATIONAL LTD. 8010379 accounts for 27% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Prosthesis, Hip, Femoral, Resurfacing in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prosthesis, Hip, Femoral, Resurfacing carries 12,333 MAUDE reports, ranked #193 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 11,997 (97.3%)
Malfunction 273 (2.2%)
Death 40 (0.3%)
17 (0.1%)
Other 6 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 9,601 (73.9%)
Other 1,839 (14.2%)
R 572 (4.4%)
Hospitalization 495 (3.8%)
324 (2.5%)
Death 59 (0.5%)
S 51 (0.4%)
O 24 (0.2%)
H 11 (0.1%)
Disability 8 (0.1%)
Congenital Anomaly 4 (0.0%)
D 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 7,443
Appropriate Device Problem Term/Code Not Available 1,249
Adverse Event Without Identified Device or Use Problem 1,025
Metal Shedding Debris 784
Loss of Osseointegration 649
Device Dislodged or Dislocated 574
Noise, Audible 571
Naturally Worn 230
Loss of or Failure to Bond 179
Corroded 170
Migration 155
Fracture 138
Malposition of Device 105
Nonstandard Device 80
Loose or Intermittent Connection 73
Osseointegration Problem 56
Degraded 52
Device Slipped 40
Material Erosion 36
Break 34

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: 16
08
2008: 22
09
2009: 11
10
2010: 67
11
2011: 556
12
2012: 1,968
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: 15
26
2026: 12

Reports rose to 15 in 2025, up from an average of 4 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Prosthesis, Hip, Femoral, Resurfacing

Event Locations

7,285 (59.1%)
I 4,754 (38.5%)
HOSPITAL 274 (2.2%)
NO INFORMATION 12 (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 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Hip, Femoral, Resurfacing: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Prosthesis, Hip, Femoral, Resurfacing are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis, Hip, Femoral, Resurfacing; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.