2024 data FDA MAUDE openFDA FDA Class III

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

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 III (highest risk, premarket approval required), regulated under 21 CFR §888.3370 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#273 of 1000 · 6,780 reports · 1993–2024

  • BOOK 6,780 reports
  • RANK #273 of 1000
  • DEATH 8 death-typed
  • INJ 6,057 injury-typed
  • MALF 464 malfunction
  • SPAN 1993–2024
  • PEAK 2009: 1,559
  • PHOTO Toothbrush, Powered

Nearest event-volume peer: Toothbrush, Powered (7 report gap)

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal sits #273 of 1000 among tracked device types with 6,780 MAUDE reports spanning 1993–2024. 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 89.3% INJURY-coded reports, 59.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 89.3% corpus 30.3% · above corpus mean (+59.0 pp)
  • MALF 6.8% corpus 64.8% · below corpus mean (-58.0 pp)

Lead product-problem code Explanted is 20% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 61% of manufacturer-tagged reports · Top event location is 55% 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, Hemi-, Acetabular, Cemented, Metal carries 6,780 MAUDE reports, ranked #273 of 1000.

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

Event Types

Injury 6,057 (89.3%)
Malfunction 464 (6.8%)
Other 213 (3.1%)
38 (0.6%)
Death 8 (0.1%)

Patient Outcomes

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

Required Intervention 4,331 (51.5%)
Hospitalization 1,625 (19.3%)
R 1,525 (18.1%)
Other 397 (4.7%)
382 (4.5%)
O 61 (0.7%)
S 34 (0.4%)
Disability 32 (0.4%)
Death 7 (0.1%)
L 5 (0.1%)
Life Threatening 5 (0.1%)
Congenital Anomaly 4 (0.0%)
H 3 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Explanted 2,260
Implant, removal of 2,197
Component(s), worn 1,616
Loose 1,235
Replace 1,080
Dislocated 819
Insufficient Device Problem Information 294
Unknown (for use when the device problem is not known) 279
Naturally Worn 276
Other (for use when an appropriate device code cannot be identified) 246
Break 186
Fracture 170
Device Dislodged or Dislocated 164
Device remains implanted 132
Disassembly 127
Device Issue 109
Component(s), broken 103
Device Slipped 101
Malposition of Device 78
Material Separation 77

Yearly Trend

93
1993: 1
94
1994: 28
95
1995: 31
96
1996: 159
97
1997: 315
98
1998: 270
99
1999: 175
00
2000: 105
01
2001: 294
02
2002: 142
03
2003: 119
04
2004: 137
05
2005: 277
06
2006: 529
07
2007: 583
08
2008: 1,026
09
2009: 1,559
10
2010: 752
11
2011: 42
12
2012: 107
13
2013: 27
14
2014: 32
15
2015: 31
16
2016: 4
17
2017: 2
18
2018: 6
19
2019: 5
20
2020: 9
21
2021: 4
22
2022: 5
24
2024: 4

Reports in 2022 (5) held close to the prior two-year average of 7.

Related Entities for Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

Event Locations

3,711 (54.7%)
HOSPITAL 2,819 (41.6%)
INVALID DATA 59 (0.9%)
OTHER 44 (0.6%)
HOME 39 (0.6%)
UNKNOWN 39 (0.6%)
I 37 (0.5%)
NOT APPLICABLE 12 (0.2%)
NO INFORMATION 11 (0.2%)
NURSING HOME 6 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS, INC. vs ZIMMER GMBH →

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 (6,780 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 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.