2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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 §888.3310 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#299 of 1000 · 5,676 reports · 1993–2026

  • BOOK 5,676 reports
  • RANK #299 of 1000
  • DEATH 21 death-typed
  • INJ 5,094 injury-typed
  • MALF 526 malfunction
  • SPAN 1993–2026
  • PEAK 2016: 1,180
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (27 report gap)

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer sits #299 of 1000 among tracked device types with 5,676 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 89.7% INJURY-coded reports, 59.5pp 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 89.7% corpus 30.3% · above corpus mean (+59.5 pp)
  • MALF 9.3% corpus 64.8% · below corpus mean (-55.6 pp)

Lead product-problem code Device Dislodged or Dislocated is 33% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 20% of manufacturer-tagged reports · Top event location I is 61% 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, Constrained, Cemented Or Uncemented, Metal/Polymer carries 5,676 MAUDE reports, ranked #299 of 1000.

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

Event Types

Injury 5,094 (89.7%)
Malfunction 526 (9.3%)
Other 31 (0.5%)
Death 21 (0.4%)
4 (0.1%)

Patient Outcomes

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

Required Intervention 2,819 (38.7%)
R 1,413 (19.4%)
Hospitalization 1,361 (18.7%)
Other 959 (13.2%)
495 (6.8%)
H 115 (1.6%)
O 76 (1.0%)
Death 23 (0.3%)
S 6 (0.1%)
Life Threatening 5 (0.1%)
Disability 4 (0.1%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Device Dislodged or Dislocated 1,956
Insufficient Device Problem Information 1,252
Adverse Event Without Identified Device or Use Problem 531
Fracture 337
Naturally Worn 245
Appropriate Device Problem Term/Code Not Available 212
Explanted 173
Break 157
Failure To Adhere Or Bond 150
Migration or Expulsion of Device 122
Dislocated 118
Implant, removal of 113
Unstable 106
Corroded 99
Disassembly 78
Difficult to Insert 73
Replace 71
Device Contaminated During Manufacture or Shipping 68
Detachment of Device or Device Component 66
Device Slipped 52

Yearly Trend

93
1993: 3
95
1995: 3
98
1998: 2
99
1999: 5
00
2000: 7
01
2001: 5
02
2002: 8
03
2003: 22
04
2004: 32
05
2005: 74
06
2006: 39
07
2007: 41
08
2008: 44
09
2009: 81
10
2010: 98
11
2011: 127
12
2012: 168
13
2013: 274
14
2014: 278
15
2015: 636
16
2016: 1,180
17
2017: 477
18
2018: 282
19
2019: 532
20
2020: 288
21
2021: 216
22
2022: 158
23
2023: 164
24
2024: 145
25
2025: 194
26
2026: 93

Reports in 2025 (194) held close to the prior two-year average of 155.

Related Entities for Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Event Locations

I 3,485 (61.4%)
1,976 (34.8%)
HOSPITAL 196 (3.5%)
NO INFORMATION 15 (0.3%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs ZIMMER, 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 (5,676 here).

Similar death-typed counts

Nearest other device types by death-typed report count (21 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.