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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

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).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#891 of 1000 · 499 reports · 2010–2026

  • BOOK 499 reports
  • RANK #891 of 1000
  • DEATH 0 death-typed
  • INJ 279 injury-typed
  • MALF 200 malfunction
  • SPAN 2010–2026
  • PEAK 2015: 115
  • PHOTO Bronchial Thermoplast…

Nearest event-volume peer: Bronchial Thermoplasty System (1 report gap)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish sits #891 of 1000 among tracked device types with 499 MAUDE reports spanning 2010–2026. 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 55.9% INJURY-coded reports, 25.6pp 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 55.9% corpus 30.3% · above corpus mean (+25.6 pp)
  • MALF 40.1% corpus 64.8% · below corpus mean (-24.7 pp)

Lead product-problem code Fracture is 17% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 38% of manufacturer-tagged reports · Top event location I is 50% 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 Cemented, Osteophilic Finish carries 499 MAUDE reports, ranked #891 of 1000.

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

Event Types

Injury 279 (55.9%)
Malfunction 200 (40.1%)
20 (4.0%)

Patient Outcomes

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

Hospitalization 197 (27.8%)
R 194 (27.4%)
Other 183 (25.8%)
70 (9.9%)
Required Intervention 48 (6.8%)
O 9 (1.3%)
H 6 (0.8%)
Life Threatening 1 (0.1%)

Top Product Problems

Fracture 96
Insufficient Device Problem Information 86
Break 81
Device Dislodged or Dislocated 63
Adverse Event Without Identified Device or Use Problem 45
Material Integrity Problem 24
Device Operates Differently Than Expected 22
Device Slipped 20
Naturally Worn 16
Appropriate Device Problem Term/Code Not Available 15
Detachment Of Device Component 15
Mechanical Problem 13
Unstable 13
Material Deformation 12
Metal Shedding Debris 12
Noise, Audible 11
Difficult to Remove 10
Fitting Problem 9
Loose or Intermittent Connection 9
Inadequacy of Device Shape and/or Size 8

Yearly Trend

10
2010: 4
11
2011: 6
12
2012: 29
13
2013: 45
14
2014: 94
15
2015: 115
16
2016: 60
17
2017: 33
18
2018: 33
19
2019: 11
20
2020: 14
21
2021: 24
22
2022: 11
23
2023: 8
24
2024: 8
25
2025: 2
26
2026: 2

Reports fell to 2 in 2025, down from an average of 8 in the two years before.

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

Top Manufacturers

STRYKER ORTHOPAEDICS-MAHWAH 161
BIOMET ORTHOPEDICS 131
ZIMMER BIOMET, INC. 76
STRYKER TRAUMA KIEL 28
STRYKER ORTHOPAEDICS CORK 20
STRYKER GMBH 9
WRIGHT MEDICAL TECHNOLOGY, INC. 2

Event Locations

I 251 (50.3%)
236 (47.3%)
HOSPITAL 5 (1.0%)
NO INFORMATION 4 (0.8%)
OTHER 2 (0.4%)
INVALID DATA 1 (0.2%)

Compare STRYKER ORTHOPAEDICS-MAHWAH 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 (499 here).

Bronchial Thermoplasty System 500 Normothermic Machine Perfusion System For T… 498 Stimulator 500 Prosthesis 497

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.