Humeris Shoulder 400-1101Recalls & reported problems
Fx Solutions · 3-4 PEGS GLENOID PE CEMENTED SIZE XS · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037301692), received between Dec 28, 2021 and Mar 3, 2022 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO ROTATOR CUFF FAILURE. APPROXIMATELY 1 YEARS AFTER FIRST SURGERY. THE SURGEON EXPLANTED 1 PEGS GLENOID (XS), 1 OFFSET HEAD COCR (41/16), 1 DOUBLE TAPER (0) AND 1 HUMERIS STEM (08). THE SURGEON IMPLANTED 1 GLENOID BASEPLATE (24MM), 1 CENTERED GLENOSPHERE (36MM), 1 HUMERAL CUP (36/+3), 1 POST EXTENSION, 2 LOCKING SCREW AND 1 STANDARD SCREW.
Patient problems: Insufficient Information
MAUDE report 13657940 ↗InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available
A REVISION SURGERY WAS PERFORMED FOR A CONVERSION FROM ANATOMIC TO REVERSE CONFIGURATION DUE TO ROTATOR CUFF FAILURE. A SIZE 41 HEAD ALONG WITH THE DOUBLE CONE TAPER AND THE GLENOID POLY WERE EXPLANTED. A 24MM GLENOID BASEPLATE, 36 MM GLENOSPHERE, 135/145 HUMERAL CUP SIZE 36/+ 3, LOCKING SCREWS SIZE 20MM & 30 MM AND A STANDARD SCREW SIZE 30 MM WERE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 13095063 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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