2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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 §888.3390 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#165 of 1000 · 16,505 reports · 1992–2026

  • BOOK 16,505 reports
  • RANK #165 of 1000
  • DEATH 49 death-typed
  • INJ 14,881 injury-typed
  • MALF 1,221 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 1,530
  • PHOTO Applier

Nearest event-volume peer: Applier, Surgical, Clip (42 report gap)

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented sits #165 of 1000 among tracked device types with 16,505 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 carries 90.2% INJURY-coded reports, 59.9pp 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 90.2% corpus 30.3% · above corpus mean (+59.9 pp)
  • MALF 7.4% corpus 64.8% · below corpus mean (-57.4 pp)

Lead product-problem code Insufficient Device Problem Information is 21% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 26% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Prosthesis 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/Polymer, Cemented Or Uncemented carries 16,505 MAUDE reports, ranked #165 of 1000.

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

Event Types

Injury 14,881 (90.2%)
Malfunction 1,221 (7.4%)
Other 306 (1.9%)
Death 49 (0.3%)
48 (0.3%)

Patient Outcomes

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

Required Intervention 10,836 (55.1%)
R 2,784 (14.1%)
Hospitalization 2,724 (13.8%)
Other 1,620 (8.2%)
1,206 (6.1%)
S 132 (0.7%)
O 124 (0.6%)
H 122 (0.6%)
Death 58 (0.3%)
Disability 34 (0.2%)
Life Threatening 18 (0.1%)
L 17 (0.1%)
Congenital Anomaly 4 (0.0%)
D 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 3,946
Device Dislodged or Dislocated 2,475
Adverse Event Without Identified Device or Use Problem 2,252
Explanted 1,610
Implant, removal of 1,170
Naturally Worn 973
Appropriate Device Problem Term/Code Not Available 793
Replace 749
Fracture 727
Loose 660
Dislocated 620
Break 504
Loss of Osseointegration 431
Metal Shedding Debris 348
Unknown (for use when the device problem is not known) 296
Component(s), worn 271
Corroded 256
Noise, Audible 232
Device Slipped 210
Loss of or Failure to Bond 190

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 1
95
1995: 25
96
1996: 74
97
1997: 149
98
1998: 168
99
1999: 108
00
2000: 75
01
2001: 87
02
2002: 64
03
2003: 91
04
2004: 91
05
2005: 168
06
2006: 264
07
2007: 371
08
2008: 901
09
2009: 963
10
2010: 689
11
2011: 756
12
2012: 977
13
2013: 1,148
14
2014: 1,055
15
2015: 1,214
16
2016: 877
17
2017: 826
18
2018: 1,380
19
2019: 1,530
20
2020: 1,259
21
2021: 276
22
2022: 208
23
2023: 178
24
2024: 209
25
2025: 182
26
2026: 138

Reports in 2025 (182) held close to the prior two-year average of 194.

Related Entities for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Event Locations

8,190 (49.6%)
I 6,936 (42.0%)
HOSPITAL 1,189 (7.2%)
INVALID DATA 52 (0.3%)
NO INFORMATION 38 (0.2%)
HOME 32 (0.2%)
UNKNOWN 29 (0.2%)
OTHER 23 (0.1%)
NOT APPLICABLE 9 (0.1%)
NURSING HOME 4 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
PUBLIC BUILDING 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare DEPUY ORTHOPAEDICS, INC. vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis: 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 (16,505 here).

Similar death-typed counts

Nearest other device types by death-typed report count (49 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis 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; 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.