2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Hip, Hemi-, Femoral, Metal Ball

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 §888.3360 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Prosthesis, Hip, Hemi-, Femoral, Metal Ball LIGHT-BOOK · MAUDE

#638 of 1000 · 1,120 reports · 1994–2026

  • BOOK 1,120 reports
  • RANK #638 of 1000
  • DEATH 3 death-typed
  • INJ 1,097 injury-typed
  • MALF 20 malfunction
  • SPAN 1994–2026
  • PEAK 2015: 97
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Suction, Patient Care (2 report gap)

Prosthesis, Hip, Hemi-, Femoral, Metal Ball sits #638 of 1000 among tracked device types with 1,120 MAUDE reports spanning 1994–2026. 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, Hip, Hemi-, Femoral, Metal Ball carries 97.9% INJURY-coded reports, 67.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 97.9% corpus 30.3% · above corpus mean (+67.7 pp)
  • MALF 1.8% corpus 64.8% · below corpus mean (-63.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 41% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 50% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Prosthesis, Hip, Hemi-, Femoral, Metal Ball in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Hip, Hemi-, Femoral, Metal Ball carries 1,120 MAUDE reports, ranked #638 of 1000.

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

Event Types

Injury 1,097 (97.9%)
Malfunction 20 (1.8%)
Death 3 (0.3%)

Patient Outcomes

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

Required Intervention 1,023 (87.7%)
R 46 (3.9%)
Hospitalization 44 (3.8%)
22 (1.9%)
Other 17 (1.5%)
O 6 (0.5%)
Death 4 (0.3%)
H 3 (0.3%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 485
Insufficient Device Problem Information 376
Device Dislodged or Dislocated 143
Implant, removal of 55
Unknown (for use when the device problem is not known) 36
Appropriate Device Problem Term/Code Not Available 18
Naturally Worn 15
Dislocated 13
Break 4
Explanted 4
Fracture 4
Inadequacy of Device Shape and/or Size 4
Metal Shedding Debris 4
Corroded 3
Device Contaminated During Manufacture or Shipping 3
Migration 3
Degraded 2
Disassembly 2
Material Deformation 2
Replace 2

Yearly Trend

94
1994: 1
00
2000: 1
02
2002: 1
05
2005: 1
06
2006: 2
07
2007: 9
08
2008: 26
09
2009: 20
10
2010: 38
11
2011: 43
12
2012: 46
13
2013: 44
14
2014: 46
15
2015: 97
16
2016: 76
17
2017: 72
18
2018: 67
19
2019: 59
20
2020: 79
21
2021: 59
22
2022: 65
23
2023: 77
24
2024: 74
25
2025: 77
26
2026: 40

Reports in 2025 (77) held close to the prior two-year average of 76.

Related Entities for Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Event Locations

649 (57.9%)
I 463 (41.3%)
HOSPITAL 6 (0.5%)
INVALID DATA 1 (0.1%)
NO INFORMATION 1 (0.1%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY ORTHOPAEDICS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Hip, Hemi-, Femoral, Metal Ball: 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 (1,120 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Hip, Hemi-, Femoral, Metal Ball 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, Hip, Hemi-, Femoral, Metal Ball; 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.