2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 §888.3353 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#103 of 1000 · 32,652 reports · 1992–2026

  • BOOK 32,652 reports
  • RANK #103 of 1000
  • DEATH 54 death-typed
  • INJ 29,382 injury-typed
  • MALF 2,937 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 3,292
  • PHOTO Pump, Infusion, Pca

Nearest event-volume peer: Pump, Infusion, Pca (11 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented sits #103 of 1000 among tracked device types with 32,652 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 90.0% INJURY-coded reports, 59.7pp 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 90.0% corpus 30.3% · above corpus mean (+59.7 pp)
  • MALF 9.0% corpus 64.8% · below corpus mean (-55.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 25% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 23% 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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented carries 32,652 MAUDE reports, ranked #103 of 1000.

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

Event Types

Injury 29,382 (90.0%)
Malfunction 2,937 (9.0%)
Other 208 (0.6%)
71 (0.2%)
Death 54 (0.2%)

Patient Outcomes

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

Required Intervention 18,276 (43.4%)
R 7,744 (18.4%)
Hospitalization 7,627 (18.1%)
Other 3,504 (8.3%)
2,801 (6.7%)
H 1,443 (3.4%)
O 433 (1.0%)
S 69 (0.2%)
Death 51 (0.1%)
Disability 42 (0.1%)
Life Threatening 38 (0.1%)
L 22 (0.1%)
Congenital Anomaly 10 (0.0%)
D 6 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 7,992
Insufficient Device Problem Information 6,035
Device Dislodged or Dislocated 5,998
Fracture 2,238
Appropriate Device Problem Term/Code Not Available 1,872
Break 1,016
Naturally Worn 788
Osseointegration Problem 687
Loose or Intermittent Connection 623
Material Erosion 537
Unstable 491
Loosening of Implant Not Related to Bone-Ingrowth 438
Noise, Audible 417
Corroded 410
Explanted 402
Device Slipped 387
Device Appears to Trigger Rejection 341
Loss of Osseointegration 341
Migration 335
Tear, Rip or Hole in Device Packaging 286

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 3
95
1995: 2
96
1996: 14
97
1997: 15
98
1998: 2
99
1999: 12
00
2000: 14
01
2001: 32
02
2002: 45
03
2003: 52
04
2004: 40
05
2005: 56
06
2006: 56
07
2007: 139
08
2008: 125
09
2009: 189
10
2010: 394
11
2011: 545
12
2012: 961
13
2013: 1,369
14
2014: 1,475
15
2015: 1,348
16
2016: 1,728
17
2017: 2,165
18
2018: 3,120
19
2019: 3,066
20
2020: 1,964
21
2021: 2,199
22
2022: 1,985
23
2023: 2,063
24
2024: 2,586
25
2025: 3,292
26
2026: 1,594

Reports rose to 3,292 in 2025, up from an average of 2,325 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Event Locations

17,244 (52.8%)
I 14,331 (43.9%)
HOSPITAL 936 (2.9%)
NO INFORMATION 78 (0.2%)
HOME 32 (0.1%)
INVALID DATA 11 (0.0%)
UNKNOWN 8 (0.0%)
OTHER 6 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
NOT APPLICABLE 1 (0.0%)
NURSING HOME 1 (0.0%)
PATIENT'S HOME 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs MEDACTA INTERNATIONAL SA →

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 (32,652 here).

Similar death-typed counts

Nearest other device types by death-typed report count (54 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.