Humeris Shoulder 400-1104Recalls & reported problems
Fx Solutions · 3-4 PEGS GLENOID PE CEMENTED SIZE L · Class 2 · Implant
- 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 03701037301722), received between Jan 17, 2025 and Jun 12, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Inadequate Osseointegration1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 105 DAYS AFTER THE PRIMARY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS, ONLY 3-4 PEGS GLENOID PE CEMENTED SIZE L AND CENTERED HEAD COCR/TIN 48X18 WAS EXPLANTED DUE TO INSTABILITY AND REPLACED WITH HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW TI/HA Ø24MM, +3MM LATERALIZED, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø36MM, HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3, CENTRAL SCREW TA6V Ø4.5MM L.14MM, LOCKING SCREW TA6V Ø4.5MM L.25MM, LOCKING SCREW TA6V Ø4.5MM L.20MM AND TWO LOCKING SCREW TA6V Ø4.5MM L.15MM.
Patient problems: Joint Laxity
MAUDE report 25491660 ↗InjuryJan 17, 2025Migration; Migration
REVISION OCCURRED ON (B)(6) 2024, APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2018. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO CHRONIC LOOSENING OF THE GLENOID. 52X21 OFFSET HEAD, 3-4 PEGS GLENOID SIZE L, AND DOUBLE TAPER CONE EXPLANTED. THESE PARTS WERE REPLACED WITH A 54X21 OFFSET HEAD, DOUBLE TAPER CONE, AND COMPETITOR GLENOID COMPONENTS.
Patient problems: Inadequate Osseointegration
MAUDE report 21183837 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.