2026 data FDA MAUDE openFDA FDA Class II

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

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 §888.3358 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Hip Prosthesis LIGHT-BOOK · MAUDE

#789 of 1000 · 673 reports · 2004–2026

  • BOOK 673 reports
  • RANK #789 of 1000
  • DEATH 0 death-typed
  • INJ 486 injury-typed
  • MALF 183 malfunction
  • SPAN 2004–2026
  • PEAK 2020: 178
  • PHOTO Forceps

Nearest event-volume peer: Forceps, General & Plastic Surgery (0 report gap)

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented sits #789 of 1000 among tracked device types with 673 MAUDE reports spanning 2004–2026. 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

Hip Prosthesis carries 72.2% INJURY-coded reports, 41.9pp 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 72.2% corpus 30.3% · above corpus mean (+41.9 pp)
  • MALF 27.2% corpus 64.8% · below corpus mean (-37.6 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 20% of coded problems · Lead manufacturer ENCORE MEDICAL L.P. accounts for 32% of manufacturer-tagged reports · Top event location I is 77% of location-tagged rows .

Hip Prosthesis in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented carries 673 MAUDE reports, ranked #789 of 1000.

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

Event Types

Injury 486 (72.2%)
Malfunction 183 (27.2%)
Other 3 (0.4%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 331 (40.7%)
135 (16.6%)
R 118 (14.5%)
Other 105 (12.9%)
Hospitalization 99 (12.2%)
O 13 (1.6%)
H 11 (1.4%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Appropriate Device Problem Term/Code Not Available 137
Adverse Event Without Identified Device or Use Problem 128
Device Dislodged or Dislocated 88
Insufficient Device Problem Information 75
Device Contaminated During Manufacture or Shipping 69
Unstable 32
Break 28
Fracture 19
Material Integrity Problem 17
Difficult to Insert 14
Packaging Problem 14
Patient Device Interaction Problem 12
Inadequacy of Device Shape and/or Size 9
Loose or Intermittent Connection 9
Manufacturing, Packaging or Shipping Problem 9
Loosening of Implant Not Related to Bone-Ingrowth 8
Unintended Movement 8
Detachment of Device or Device Component 7
Device Operates Differently Than Expected 7
Material Deformation 7

Yearly Trend

04
2004: 1
13
2013: 5
14
2014: 31
15
2015: 52
16
2016: 45
17
2017: 27
18
2018: 39
19
2019: 104
20
2020: 178
21
2021: 88
22
2022: 32
23
2023: 18
24
2024: 20
25
2025: 16
26
2026: 17

Reports in 2025 (16) held close to the prior two-year average of 19.

Related Entities for Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Event Locations

I 516 (76.7%)
151 (22.4%)
HOSPITAL 4 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
NO INFORMATION 1 (0.1%)

Compare ENCORE MEDICAL L.P. vs ZIMMER BIOMET, INC. →

Nationwide devices with a comparable report-volume footprint

Hip 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 (673 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Hip 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 Hip 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.