2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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 §888.3358 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#43 of 1000 · 89,781 reports · 1992–2026

  • BOOK 89,781 reports
  • RANK #43 of 1000
  • DEATH 195 death-typed
  • INJ 82,346 injury-typed
  • MALF 6,665 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 7,130
  • PHOTO System

Nearest event-volume peer: System, X-Ray, Fluoroscopic, Image-Intensified (825 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented sits #43 of 1000 among tracked device types with 89,781 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 91.7% INJURY-coded reports, 61.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 91.7% corpus 30.3% · above corpus mean (+61.4 pp)
  • MALF 7.4% corpus 64.8% · below corpus mean (-57.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 38% of manufacturer-tagged reports · Top event location is 53% 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, Semi-Constrained, Metal/Polymer, Porous Uncemented carries 89,781 MAUDE reports, ranked #43 of 1000.

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

Event Types

Injury 82,346 (91.7%)
Malfunction 6,665 (7.4%)
Other 471 (0.5%)
Death 195 (0.2%)
104 (0.1%)

Patient Outcomes

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

Required Intervention 57,265 (51.2%)
R 18,220 (16.3%)
Hospitalization 17,940 (16.0%)
Other 8,230 (7.4%)
5,479 (4.9%)
H 3,249 (2.9%)
O 851 (0.8%)
Death 230 (0.2%)
S 227 (0.2%)
Disability 70 (0.1%)
Life Threatening 64 (0.1%)
L 43 (0.0%)
D 30 (0.0%)
Congenital Anomaly 16 (0.0%)
C 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 22,851
Insufficient Device Problem Information 17,316
Device Dislodged or Dislocated 15,235
Naturally Worn 5,505
Appropriate Device Problem Term/Code Not Available 4,288
Loss of Osseointegration 4,101
Fracture 3,970
Corroded 2,584
Osseointegration Problem 2,493
Implant, removal of 2,111
Explanted 2,088
Malposition of Device 2,070
Material Erosion 1,872
Degraded 1,484
Break 1,461
Noise, Audible 1,286
Disassembly 1,282
Metal Shedding Debris 1,170
Difficult to Insert 1,106
Unstable 1,031

Yearly Trend

92
1992: 1
93
1993: 3
94
1994: 1
96
1996: 15
97
1997: 3
98
1998: 9
99
1999: 38
00
2000: 69
01
2001: 801
02
2002: 196
03
2003: 222
04
2004: 153
05
2005: 293
06
2006: 307
07
2007: 509
08
2008: 706
09
2009: 1,156
10
2010: 2,004
11
2011: 3,312
12
2012: 3,766
13
2013: 5,002
14
2014: 5,163
15
2015: 5,829
16
2016: 4,901
17
2017: 5,312
18
2018: 5,938
19
2019: 7,130
20
2020: 5,430
21
2021: 5,978
22
2022: 5,223
23
2023: 5,346
24
2024: 5,627
25
2025: 6,245
26
2026: 3,093

Reports in 2025 (6,245) held close to the prior two-year average of 5,487.

Related Entities for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Event Locations

47,675 (53.1%)
I 39,557 (44.1%)
HOSPITAL 2,403 (2.7%)
NO INFORMATION 113 (0.1%)
OTHER 15 (0.0%)
HOME 7 (0.0%)
INVALID DATA 7 (0.0%)
UNKNOWN 3 (0.0%)
NURSING HOME 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs STRYKER ORTHOPAEDICS-MAHWAH →

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 (89,781 here).

Similar death-typed counts

Nearest other device types by death-typed report count (195 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.