2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Hemi-, Femoral, Metal

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 §888.3360 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis, Hip, Hemi-, Femoral, Metal LIGHT-BOOK · MAUDE

#435 of 1000 · 2,683 reports · 1994–2026

  • BOOK 2,683 reports
  • RANK #435 of 1000
  • DEATH 4 death-typed
  • INJ 2,029 injury-typed
  • MALF 610 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 415
  • PHOTO Intraocular Pressure…

Nearest event-volume peer: Intraocular Pressure Lowering Implant (12 report gap)

Prosthesis, Hip, Hemi-, Femoral, Metal sits #435 of 1000 among tracked device types with 2,683 MAUDE reports spanning 1994–2026. 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, Hemi-, Femoral, Metal carries 75.6% INJURY-coded reports, 45.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 75.6% corpus 30.3% · above corpus mean (+45.3 pp)
  • MALF 22.7% corpus 64.8% · below corpus mean (-42.1 pp)

Lead product-problem code Insufficient Device Problem Information is 21% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 26% of manufacturer-tagged reports · Top event location I is 66% of location-tagged rows .

Prosthesis, Hip, Hemi-, Femoral, Metal in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Hip, Hemi-, Femoral, Metal carries 2,683 MAUDE reports, ranked #435 of 1000.

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

Event Types

Injury 2,029 (75.6%)
Malfunction 610 (22.7%)
Other 36 (1.3%)
4 (0.1%)
Death 4 (0.1%)

Patient Outcomes

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

Required Intervention 1,418 (43.4%)
562 (17.2%)
R 483 (14.8%)
Hospitalization 437 (13.4%)
Other 254 (7.8%)
H 62 (1.9%)
O 36 (1.1%)
Death 6 (0.2%)
S 4 (0.1%)
L 2 (0.1%)
Disability 2 (0.1%)
Life Threatening 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 594
Adverse Event Without Identified Device or Use Problem 393
Loss of Osseointegration 250
Device-Device Incompatibility 204
Appropriate Device Problem Term/Code Not Available 201
Device Dislodged or Dislocated 189
Break 145
Biocompatibility 117
Material Twisted/Bent 113
Fracture 81
Corroded 78
Scratched Material 77
Fitting Problem 62
Migration or Expulsion of Device 62
Naturally Worn 58
Loose or Intermittent Connection 53
Explanted 49
Degraded 38
Loss of or Failure to Bond 38
Osseointegration Problem 37

Yearly Trend

94
1994: 2
96
1996: 1
99
1999: 1
00
2000: 4
02
2002: 6
03
2003: 16
04
2004: 4
05
2005: 12
06
2006: 11
07
2007: 11
08
2008: 13
09
2009: 21
10
2010: 55
11
2011: 51
12
2012: 62
13
2013: 89
14
2014: 107
15
2015: 223
16
2016: 210
17
2017: 347
18
2018: 294
19
2019: 415
20
2020: 270
21
2021: 107
22
2022: 99
23
2023: 48
24
2024: 143
25
2025: 29
26
2026: 32

Reports fell to 29 in 2025, down from an average of 96 in the two years before.

Related Entities for Prosthesis, Hip, Hemi-, Femoral, Metal

Event Locations

I 1,772 (66.0%)
850 (31.7%)
HOSPITAL 46 (1.7%)
NO INFORMATION 11 (0.4%)
INVALID DATA 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare STRYKER ORTHOPAEDICS-MAHWAH vs DEPUY IRELAND - 9616671 →

Nationwide devices with a comparable volume-and-death footprint

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

Similar report volume

Nearest other device types by FDA MAUDE report count (2,683 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Hip, Hemi-, Femoral, Metal 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, Hemi-, Femoral, Metal; 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.