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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 §888.3360 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#350 of 1000 · 4,170 reports · 1992–2026

  • BOOK 4,170 reports
  • RANK #350 of 1000
  • DEATH 13 death-typed
  • INJ 3,780 injury-typed
  • MALF 332 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 522
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Manual, Surgical, General Use (27 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented sits #350 of 1000 among tracked device types with 4,170 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 90.6% INJURY-coded reports, 60.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 90.6% corpus 30.3% · above corpus mean (+60.4 pp)
  • MALF 8.0% corpus 64.8% · below corpus mean (-56.9 pp)

Lead product-problem code Break is 20% of coded problems · Lead manufacturer MICROPORT ORTHOPEDICS INC. accounts for 43% of manufacturer-tagged reports · Top event location HOSPITAL is 42% 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, Uncemented carries 4,170 MAUDE reports, ranked #350 of 1000.

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

Event Types

Injury 3,780 (90.6%)
Malfunction 332 (8.0%)
Other 24 (0.6%)
21 (0.5%)
Death 13 (0.3%)

Patient Outcomes

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

Required Intervention 2,838 (55.4%)
R 840 (16.4%)
Hospitalization 816 (15.9%)
286 (5.6%)
Other 207 (4.0%)
H 39 (0.8%)
S 36 (0.7%)
O 31 (0.6%)
Death 16 (0.3%)
L 4 (0.1%)
Disability 4 (0.1%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 875
Insufficient Device Problem Information 830
Adverse Event Without Identified Device or Use Problem 634
Fracture 321
Device Dislodged or Dislocated 269
Explanted 222
Unknown (for use when the device problem is not known) 183
Corroded 139
Loose or Intermittent Connection 123
Loss of Osseointegration 114
Appropriate Device Problem Term/Code Not Available 80
Replace 75
Component(s), broken 70
Naturally Worn 62
Component(s), worn 61
Metal Shedding Debris 61
Loose 55
Migration or Expulsion of Device 42
Device Slipped 41
Dull, Blunt 36

Yearly Trend

92
1992: 1
96
1996: 2
97
1997: 4
98
1998: 3
99
1999: 8
00
2000: 5
01
2001: 7
02
2002: 24
03
2003: 34
04
2004: 29
05
2005: 46
06
2006: 38
07
2007: 68
08
2008: 72
09
2009: 84
10
2010: 132
11
2011: 255
12
2012: 390
13
2013: 522
14
2014: 452
15
2015: 310
16
2016: 293
17
2017: 311
18
2018: 227
19
2019: 210
20
2020: 189
21
2021: 155
22
2022: 91
23
2023: 72
24
2024: 54
25
2025: 52
26
2026: 30

Reports in 2025 (52) held close to the prior two-year average of 63.

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

Top Manufacturers

MICROPORT ORTHOPEDICS INC. 1,362
WRIGHT MEDICAL TECHNOLOGY, INC. 1,132
STRYKER ORTHOPAEDICS-MAHWAH 186
ZIMMER, INC. 176
DEPUY ORTHOPAEDICS, INC. 91
AESCULAP AG 84
DEPUY ORTHOPAEDICS INC US 79
STRYKER ORTHOPAEDICS MAHWAH 63

Event Locations

HOSPITAL 1,733 (41.6%)
I 1,329 (31.9%)
1,090 (26.1%)
NO INFORMATION 6 (0.1%)
OTHER 6 (0.1%)
INVALID DATA 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOME 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare MICROPORT ORTHOPEDICS INC. vs WRIGHT MEDICAL TECHNOLOGY, INC. →

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 (4,170 here).

Instrument, Manual, Surgical, General Use 4,143 Stretcher, Wheeled, Powered 4,226 Catheter, Straight 4,229 Battery, Replacement, Rechargeable 4,301

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 13

Read our methodology - how this data is sourced, computed, and verified.

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.