2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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).

FDA MAUDE casebook

openFDA event book Prosthesis MID-BOOK · MAUDE

#217 of 1000 · 10,185 reports · 1997–2026

  • BOOK 10,185 reports
  • RANK #217 of 1000
  • DEATH 13 death-typed
  • INJ 9,050 injury-typed
  • MALF 1,065 malfunction
  • SPAN 1997–2026
  • PEAK 2012: 1,604
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (10 report gap)

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate sits #217 of 1000 among tracked device types with 10,185 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 88.9% INJURY-coded reports, 58.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 88.9% corpus 30.3% · above corpus mean (+58.6 pp)
  • MALF 10.5% corpus 64.8% · below corpus mean (-54.4 pp)

Lead product-problem code Insufficient Device Problem Information is 27% of coded problems · Lead manufacturer STRYKER ORTHOPAEDICS-MAHWAH accounts for 40% of manufacturer-tagged reports · Top event location is 75% 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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate carries 10,185 MAUDE reports, ranked #217 of 1000.

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

Event Types

Injury 9,050 (88.9%)
Malfunction 1,065 (10.5%)
Other 35 (0.3%)
22 (0.2%)
Death 13 (0.1%)

Patient Outcomes

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

Required Intervention 4,178 (30.5%)
Other 3,157 (23.0%)
R 2,971 (21.7%)
Hospitalization 2,242 (16.4%)
547 (4.0%)
H 314 (2.3%)
O 229 (1.7%)
S 33 (0.2%)
Disability 14 (0.1%)
Death 11 (0.1%)
L 5 (0.0%)
Life Threatening 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 2,682
Adverse Event Without Identified Device or Use Problem 1,242
Device Dislodged or Dislocated 776
Device Slipped 696
Appropriate Device Problem Term/Code Not Available 410
Device-Device Incompatibility 394
Fracture 394
Device Operates Differently Than Expected 377
Nonstandard Device 368
Break 361
Mechanical Problem 334
Explanted 324
Loose or Intermittent Connection 237
Metal Shedding Debris 220
Corroded 206
Loose 180
Osseointegration Problem 165
Naturally Worn 160
Replace 152
Malposition of Device 132

Yearly Trend

97
1997: 2
99
1999: 1
00
2000: 11
01
2001: 8
02
2002: 14
03
2003: 13
04
2004: 9
05
2005: 19
06
2006: 21
07
2007: 25
08
2008: 261
09
2009: 539
10
2010: 462
11
2011: 419
12
2012: 1,604
13
2013: 1,295
14
2014: 1,196
15
2015: 490
16
2016: 347
17
2017: 383
18
2018: 337
19
2019: 335
20
2020: 338
21
2021: 372
22
2022: 316
23
2023: 334
24
2024: 353
25
2025: 474
26
2026: 207

Reports in 2025 (474) held close to the prior two-year average of 344.

Related Entities for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Event Locations

7,684 (75.4%)
I 2,277 (22.4%)
HOSPITAL 137 (1.3%)
AMBULATORY SURGICAL FACILITY 59 (0.6%)
NO INFORMATION 23 (0.2%)
OTHER 2 (0.0%)
HOME 1 (0.0%)
INVALID DATA 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare STRYKER ORTHOPAEDICS-MAHWAH vs STRYKER ORTHOPAEDICS CORK →

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 (10,185 here).

Similar death-typed counts

Nearest other device types by death-typed report count (13 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.