2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3660 (Orthopedic panel).

FDA MAUDE casebook

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

#190 of 1000 · 12,771 reports · 2015–2026

  • BOOK 12,771 reports
  • RANK #190 of 1000
  • DEATH 11 death-typed
  • INJ 11,323 injury-typed
  • MALF 1,437 malfunction
  • SPAN 2015–2026
  • PEAK 2025: 2,889
  • PHOTO Recorder

Nearest event-volume peer: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (45 report gap)

Shoulder Prosthesis, Reverse Configuration sits #190 of 1000 among tracked device types with 12,771 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 →

Injury-coded reports run above the device-type norm

Shoulder Prosthesis, Reverse Configuration carries 88.7% INJURY-coded reports, 58.4pp 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 88.7% corpus 30.3% · above corpus mean (+58.4 pp)
  • MALF 11.3% corpus 64.8% · below corpus mean (-53.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer ZIMMER BIOMET, INC. accounts for 28% of manufacturer-tagged reports · Top event location is 77% 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 12,771 MAUDE reports, ranked #190 of 1000.

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

Event Types

Injury 11,323 (88.7%)
Malfunction 1,437 (11.3%)
Death 11 (0.1%)

Patient Outcomes

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

Required Intervention 7,172 (44.5%)
Hospitalization 2,227 (13.8%)
R 2,211 (13.7%)
Other 1,960 (12.2%)
1,317 (8.2%)
H 950 (5.9%)
O 231 (1.4%)
S 13 (0.1%)
Disability 12 (0.1%)
L 8 (0.0%)
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 5,001
Device Dislodged or Dislocated 2,421
Appropriate Device Problem Term/Code Not Available 1,349
Fracture 913
Unstable 708
Loosening of Implant Not Related to Bone-Ingrowth 490
Break 428
Detachment of Device or Device Component 413
Patient Device Interaction Problem 366
Osseointegration Problem 242
Difficult to Insert 178
Loose or Intermittent Connection 177
Naturally Worn 164
Insufficient Device Problem Information 147
Migration 110
Positioning Failure 109
Loss of Osseointegration 98
Device Appears to Trigger Rejection 84
Device-Device Incompatibility 68
Unintended Movement 68

Yearly Trend

15
2015: 14
16
2016: 5
17
2017: 25
18
2018: 296
19
2019: 504
20
2020: 990
21
2021: 1,404
22
2022: 1,342
23
2023: 1,402
24
2024: 2,142
25
2025: 2,889
26
2026: 1,758

Reports rose to 2,889 in 2025, up from an average of 1,772 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Shoulder Prosthesis, Reverse Configuration

Event Locations

9,889 (77.4%)
I 2,704 (21.2%)
HOSPITAL 173 (1.4%)
NO INFORMATION 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Shoulder Prosthesis, Reverse Configuration: 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 (12,771 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.