Humeris Shoulder 400-1102Recalls & reported problems
Fx Solutions · 3-4 PEGS GLENOID PE CEMENTED SIZE S · 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 03701037301708), received between May 27, 2021 and Jul 19, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Microbial Contamination of Device1
Patient problems
- Insufficient Information1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A DOUBLE TAPER, A PEGS GLENOID, AN OFFSET HEAD AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A POST EXTENSION AND SCREWS WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17348839 ↗InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO CUFF TEAR THAT OCCURED APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE EASYTECH ANATOMICAL SYSTEM. THE SURGEON CONVERTED IT TO A REVERSED SYSTEM. HE EXPLANTED THE SIZE S/ 4 PEGS GLENOID, THE 43 X 16 CENTERED HEAD AND THE +0MM DOUBLE TAPER. THEN HE IMPLANTED A 36/+3 135/145 HUMERAL CUP, A 24 BASEPLATE, A 36 GLENOSPHERE AND ASSOCIATED SCREWS.
Patient problems: Insufficient Information
MAUDE report 11892123 ↗
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.