PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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 §888.3800 (Orthopedic panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#893 of 1000 · 497 reports · 1997–2026

  • BOOK 497 reports
  • RANK #893 of 1000
  • DEATH 0 death-typed
  • INJ 460 injury-typed
  • MALF 35 malfunction
  • SPAN 1997–2026
  • PEAK 2019: 127
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Vancomycin (0 report gap)

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained sits #893 of 1000 among tracked device types with 497 MAUDE reports spanning 1997–2026. 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 92.6% INJURY-coded reports, 62.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 92.6% corpus 30.3% · above corpus mean (+62.3 pp)
  • MALF 7.0% corpus 64.8% · below corpus mean (-57.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 38% of coded problems · Lead manufacturer STRYKER GMBH accounts for 60% of manufacturer-tagged reports · Top event location I is 58% 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, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained carries 497 MAUDE reports, ranked #893 of 1000.

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

Event Types

Injury 460 (92.6%)
Malfunction 35 (7.0%)
1 (0.2%)
Other 1 (0.2%)

Patient Outcomes

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

Required Intervention 187 (30.5%)
Other 164 (26.8%)
Hospitalization 114 (18.6%)
R 106 (17.3%)
29 (4.7%)
O 8 (1.3%)
H 4 (0.7%)
S 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 189
Insufficient Device Problem Information 67
Loosening of Implant Not Related to Bone-Ingrowth 31
Migration 31
Material Disintegration 21
Loss of Osseointegration 20
Migration or Expulsion of Device 18
Break 16
Naturally Worn 15
Loose or Intermittent Connection 14
Fracture 10
Inadequacy of Device Shape and/or Size 9
Appropriate Device Problem Term/Code Not Available 8
Device Dislodged or Dislocated 7
Patient-Device Incompatibility 7
Therapeutic or Diagnostic Output Failure 7
Device Slipped 6
Material Erosion 6
Osseointegration Problem 6
Device Operates Differently Than Expected 4

Yearly Trend

97
1997: 1
98
1998: 1
99
1999: 1
05
2005: 2
08
2008: 1
09
2009: 4
10
2010: 5
11
2011: 4
12
2012: 7
13
2013: 9
14
2014: 11
15
2015: 7
16
2016: 48
17
2017: 37
18
2018: 31
19
2019: 127
20
2020: 34
21
2021: 8
22
2022: 65
23
2023: 26
24
2024: 18
25
2025: 8
26
2026: 42

Reports fell to 8 in 2025, down from an average of 22 in the two years before.

Related Entities for Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Top Manufacturers

STRYKER GMBH 255
BIOMET ORTHOPEDICS 84
ZIMMER BIOMET, INC. 45
INTEGRA LIFESCIENCES CORPORATION OH/USA 27
DEPUY ORTHOPAEDICS INC US 6
DEPUY ORTHOPAEDICS, INC. 5

Event Locations

I 287 (57.7%)
200 (40.2%)
HOSPITAL 9 (1.8%)
NO INFORMATION 1 (0.2%)

Compare STRYKER GMBH vs BIOMET ORTHOPEDICS →

Nationwide devices with a comparable report-volume footprint

Prosthesis carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (497 here).

Radioimmunoassay, Vancomycin 497 Normothermic Machine Perfusion System For T… 498 Glue, Surgical, Arteries 495 Prosthesis 499

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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.