2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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 §888.3350 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#57 of 1000 · 70,458 reports · 1993–2026

  • BOOK 70,458 reports
  • RANK #57 of 1000
  • DEATH 255 death-typed
  • INJ 64,301 injury-typed
  • MALF 5,465 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 7,407
  • PHOTO System

Nearest event-volume peer: System, Endovascular Graft, Aortic Aneurysm Treatment (1,346 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented sits #57 of 1000 among tracked device types with 70,458 MAUDE reports spanning 1993–2026. 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 91.3% INJURY-coded reports, 61.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 91.3% corpus 30.3% · above corpus mean (+61.0 pp)
  • MALF 7.8% corpus 64.8% · below corpus mean (-57.1 pp)

Lead product-problem code Insufficient Device Problem Information is 26% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 28% of manufacturer-tagged reports · Top event location I is 57% 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, Cemented carries 70,458 MAUDE reports, ranked #57 of 1000.

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

Event Types

Injury 64,301 (91.3%)
Malfunction 5,465 (7.8%)
Other 302 (0.4%)
Death 255 (0.4%)
135 (0.2%)

Patient Outcomes

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

Required Intervention 40,011 (45.7%)
R 14,700 (16.8%)
Hospitalization 14,148 (16.1%)
Other 11,002 (12.6%)
4,602 (5.3%)
H 1,521 (1.7%)
O 806 (0.9%)
Death 332 (0.4%)
S 317 (0.4%)
Disability 88 (0.1%)
Life Threatening 44 (0.1%)
L 35 (0.0%)
Congenital Anomaly 23 (0.0%)
D 15 (0.0%)

Top Product Problems

Insufficient Device Problem Information 21,682
Adverse Event Without Identified Device or Use Problem 11,733
Device Dislodged or Dislocated 10,332
Naturally Worn 8,226
Appropriate Device Problem Term/Code Not Available 4,720
Explanted 2,852
Implant, removal of 2,702
Fracture 2,631
Metal Shedding Debris 2,444
Corroded 2,045
Break 1,924
Noise, Audible 1,676
Dislocated 1,530
Loss of Osseointegration 1,515
Material Disintegration 1,401
Replace 1,149
Loose 1,004
Degraded 991
Loss of or Failure to Bond 877
Device Operates Differently Than Expected 815

Yearly Trend

93
1993: 2
94
1994: 8
95
1995: 38
96
1996: 59
97
1997: 152
98
1998: 132
99
1999: 146
00
2000: 135
01
2001: 221
02
2002: 214
03
2003: 227
04
2004: 231
05
2005: 571
06
2006: 939
07
2007: 696
08
2008: 811
09
2009: 964
10
2010: 2,043
11
2011: 3,137
12
2012: 5,110
13
2013: 5,206
14
2014: 4,968
15
2015: 4,904
16
2016: 3,996
17
2017: 6,135
18
2018: 6,726
19
2019: 7,407
20
2020: 4,014
21
2021: 3,170
22
2022: 1,978
23
2023: 1,635
24
2024: 1,821
25
2025: 1,670
26
2026: 992

Reports in 2025 (1,670) held close to the prior two-year average of 1,728.

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

Event Locations

I 39,907 (56.6%)
27,442 (38.9%)
HOSPITAL 2,780 (3.9%)
NO INFORMATION 128 (0.2%)
HOME 76 (0.1%)
UNKNOWN 48 (0.1%)
INVALID DATA 37 (0.1%)
OTHER 26 (0.0%)
AMBULATORY SURGICAL FACILITY 9 (0.0%)
NOT APPLICABLE 4 (0.0%)
NURSING HOME 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs ZIMMER BIOMET, 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 (70,458 here).

Similar death-typed counts

Nearest other device types by death-typed report count (255 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.