2026 data FDA MAUDE openFDA

Shoulder Prosthesis, Reverse Configuration

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 MAUDE casebook

openFDA event book Shoulder Prosthesis, Reverse Configuration MID-BOOK · MAUDE

#194 of 1000 · 11,527 reports · 2015–2026

  • BOOK 11,527 reports
  • RANK #194 of 1000
  • DEATH 11 death-typed
  • INJ 10,204 injury-typed
  • MALF 1,312 malfunction
  • SPAN 2015–2026
  • PEAK 2025: 2,887
  • PHOTO Mesh, Surgical

Nearest event-volume peer: Mesh, Surgical (6 report gap)

Shoulder Prosthesis, Reverse Configuration sits #194 of 1000 among tracked device types with 11,527 MAUDE reports spanning 2015–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 88.5% corpus 30.4% · above corpus mean (+58.1 pp)
  • MALF 11.4% corpus 64.5% · below corpus mean (-53.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 28% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Shoulder Prosthesis, Reverse Configuration in the event-volume neighbourhood

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

reports

What this shows Shoulder Prosthesis, Reverse Configuration carries 11,527 MAUDE reports, ranked #194 of 1000.

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

Event Types

Injury 10,204 (88.5%)
Malfunction 1,312 (11.4%)
Death 11 (0.1%)

Patient Outcomes

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

Required Intervention 6,452 (44.0%)
R 2,087 (14.2%)
Hospitalization 2,076 (14.2%)
Other 1,741 (11.9%)
1,207 (8.2%)
H 837 (5.7%)
O 220 (1.5%)
S 12 (0.1%)
Disability 9 (0.1%)
L 8 (0.1%)
D 5 (0.0%)
Death 5 (0.0%)
Life Threatening 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 4,456
Device Dislodged or Dislocated 2,195
Appropriate Term/Code Not Available 1,347
Fracture 814
Unstable 596
Loosening of Implant Not Related to Bone-Ingrowth 442
Break 419
Detachment of Device or Device Component 364
Patient Device Interaction Problem 264
Osseointegration Problem 219
Loose or Intermittent Connection 177
Difficult to Insert 167
Naturally Worn 151
Insufficient Information 130
Migration 99
Positioning Failure 91
Loss of Osseointegration 85
Device Appears to Trigger Rejection 74
Device-Device Incompatibility 68
Unintended Movement 63

Yearly Trend

15
2015: 14
16
2016: 5
17
2017: 25
18
2018: 296
19
2019: 504
20
2020: 986
21
2021: 1,404
22
2022: 1,342
23
2023: 1,402
24
2024: 2,143
25
2025: 2,887
26
2026: 519

Related Entities for Shoulder Prosthesis, Reverse Configuration

Event Locations

8,645 (75.0%)
I 2,705 (23.5%)
HOSPITAL 172 (1.5%)
NO INFORMATION 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Shoulder Prosthesis, Reverse Configuration, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (11,527 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Shoulder Prosthesis, Reverse Configuration 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 Shoulder Prosthesis, Reverse Configuration; 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.